First Aid ANSI Standards Updated

March 30, 2015

DHSK01_lrAmerican National Standards Institute (ANSI) has released updated guidelines for the minimum requirements of first aid kits for 2015. Take a look at the charts below to compare these new guidelines to the previous ones. And, rest assured, that all Think Safe first aid kits are ANSI compliant.

 

ANSI/ISEA Z308.1 – 2009

Minimum Quantity Requirements for Unit Packaging

Unit First Aid Supply
Minimum Size or Volume – US
Minimum Size of Volume – metric
Supply Quantity per unit package

Absorbent Compress
32 sq. in.
206 sq. cm
1

Adhesive Bandage
1 x 3 in.
2.5 x 7.5 cm
16

Adhesive Tape
2.5 yd (total)
2.3 m
1 or 2

Antibiotic Treatment
0.14 fl oz.
0.5 g
6

Antiseptic Swab
0.14 fl oz.
0.5 g
10

Antiseptic Wipe
1 x 1 in.
2.5 x 2.5 cm
10

Antiseptic Towelette
24 sq. in.
157 sq. cm
10

Bandage Compress (2 in.)
2 x 36 in.
5 x 91 cm
4

Bandage Compress (3 in.)
3 x 60 in.
7.5 x 152 cm
2

Bandage Compress (4 in.)
4 x 72 in.
10 x 183 cm
1

Breathing Barrier
blank
blank
1

Burn Dressing
4 x 4 in.
10 x 10 cm
1

Burn Treatment
1/32 oz.
0.9 g
6

Cold Pack
4 x 5 in.
10 x 12.5 cm
1

Eye Covering, with means of attachment
2.9 sq. in.
19 sq. cm
2

Eye/Skin Wash
4 fl. oz. total
118 ml total
1

Eye/Skin Wash & Covering,
4 fl. oz. total
118 ml total
1

with means of attachment
2.9 sq. in.
19 sq. cm
2

Gloves
blank
blank
2 pair

Hand Sanitizer
1/32 oz.
0.9 g
6

Roller Bandage (4 in.)
4 in. x 4 yd.
10 x 366 cm
1

Roller Bandage (2 in.)
2 in. x 4 yd.
5 x 366 cm
2

Sterile pad
3 x 3 in.
7.5 x 7.5 cm
4

Triangular Bandage
40 x 40 x 56 in.
101x 101 x 142 cm
1


ANSI/ISEA Z308.1 -2015

Classes of First Aid Kits and Required Supplies

First Aid Supply
Minimum Quantity
Minimum Size of Volume

blank
Class A Kits
Class B Kits
(US)
(Metric)

Adhesive Bandage
16
50
1 x 3 in.
2.5 x 7.5 cm

Adhesive Tape
1
2
2.5 yd (total)
2.3m

Antibiotic Application
10
25
1/57 oz
0.5 g

Antiseptic
10
50
1/57 oz
0.5g

Breathing Barrier
1
1
blank
blank

Bum Dressing (gel soaked)
1
2
4 x 4 in
10 x 10 cm

Burn Treatment
10
25
1/32 oz
0.9 g

Cold Pack
1
2
4 x 5 in.
10 x 12.5 cm

Eye Covering with means of attachment
2
2
2.9 sq. in
19 sq. cm

Eye/Skin Wash
 
 
 
 

blank
1 fl oz total
blank
blank
29.6 ml

blank
blank
4 fl oz total
blank
118.3 ml

First Aid Guide
1
1
N/A
N/A

Hand Sanitizer
6
10
1/32 oz
0.9 g

Medical Exam Gloves
2 pair
4 pair
N/A
N/A

Roller Bandage
 
 
 
 

2 inch
1
2
2 in. x 4 yd
5 cm x 3.66m

4 inch
0
1
4 in. x 4 yd
10 cm x 3.66m

Scissors
1
1
N/A
N/A

Splint
0
1
4.0 x 24 in.
10.2 x 61 cm

Sterile pad
2
4
3 x 3 in
7.5 x 7.5 cm

Tourniquet
0
1
1 in. (width)
2.5 cm (width)

Trauma pad
2
4
5 x 9 in.
12.7 x 22.9 cm

Triangular Bandage
1
2
40 x 40 x 56 in.
101 x 101 x 142 cm


To learn more about these guideline updates or for any other questions, simply click the More Information button below, we’ll be happy to help! 

More Information

BEWARE: Brown Recluse Spider Bite

November 14, 2014
This is a First Aid training student’s pictures of his own experience with a Brown Recluse Spider bite.

This is a First Aid training student’s pictures of his own experience with a Brown Recluse Spider bite.

 

 

 

 

 

 

 

 

 

 

 

 

 

Think Safe provides First Aid training courses! Online, in-person, and blended options are available.

Click here to visit our training page!

If you would like more information on First Aid or CPR training, please complete the following form and we’ll promptly contact you! 


Think Safe, Unique Life-saving Iowa Company, Receives Patent

June 12, 2014
US Patent 8,647,123B1 Issued to Iowa Company and Founders Paula Wickham & Annette Carter

US Patent 8,647,123B1 Issued to Iowa Company and Founders Paula Wickham & Annette Carter

Think Safe, a Cedar Rapids, IA based company and homegrown Iowa business that started from scratch, based upon the idea of an Iowa citizen, received its first patent in early 2014.  The idea formed what is now known as an Emergency Instruction Device (EID), a technology product being marketed all over the US and in other countries. On February 11, 2014, US Patent8,647,123 was issued and assigned to Retrac, Inc. (now doing business as Think Safe Inc. in Cedar Rapids, Iowa) and company founders and inventors.

Emergency Instruction Device (EID)

Emergency Instruction Device (EID)

The EID patent is a major milestone for Think Safe, which was originally founded in 2004 centrally focused on the idea of the EID.  The EID is often called a CPR & First Aid Assistance device, first aid tablet or talking first aid book and is the only dedicated technology device on the market today that offers first aid and CPR instructions to minimally trained or even untrained people during workplace or public rescue situations.  Key details of product functionality include American Heart Association compliance to cognitive feedback device recommendations, as seen here:  http://www.firstvoice.us/Products/FirstAidCPRAssist/tabid/790/Default.aspx.

The idea behind the EID  product was conceived by Annette Carter, a former flight nurse for St. Luke’s Hospital, to bring resources and knowledge during critical gaps in time between when a trauma occurs and when advanced medical help arrives.  Annette, during her long career of pre-hospital trauma care, saw how such a device could  help make a difference. Today, the Think Safe logo is “Making Minutes Matter” to emphasize the foundation values that remain important to the company going forward.

Dr. Donald Linder with the Emergency Instruction Device outside his hospital in Cedar Rapids, IA.

Dr. Donald Linder with the Emergency Instruction Device outside his hospital in Cedar Rapids, IA

The EID and responder kit systems that can be bundled with the EID provide not only essential and organized medical supplies,  but also audio and text instructions to coach people through emergency situations until help arrives.  Annette’s vision became a reality with the help of several co-inventors listed on the patent: Paula Wickham , Kirk Dighton, and Troy Mundt, who all served various roles in pre-market research or market introduction and sales or distribution of the EID.  The device has been beneficial during many lifesaving situations and testimonials shared by clients, and has had key endorsements in its short lifespan to date (click here for more details). 

The EID or “first aid tablet” can guide people through any major or minor first aid emergency and giving reminders or when to: call 911, check scene safety, use personal protection, provide treatment instructions including information on what not to do,  or what to do after the incident, including key tips on information record keeping or scene cleanup procedures.  Since its’ invention, the EID functionality has been converted to software that can work with any computer or technology device with WiFi access or downloaded software (ResQr) developed by Think Safe.  However, the EID continues to be Think Safe’s signature technology product and the company is proud of the lives it has helped to save as well as the awards we have received that showcase the innovation of the company.

First Voice Systems include an EID and other equipment such as an AED or first aid kit

First Voice Systems include an EID and other equipment such as an AED or first aid kit

The EID is often paired with various specialty first aid or responder kits or an Automated External Defibrillator (AED), depending on risks that exist at the client’s organization or workplace.  Think Safe is an established manufacturer, wholesaler, training services provider, and overall integrator, bringing clients the products and services packages that they need or want to help mitigate risks, decrease panic, and provide confidence during emergency, first aid, or medical illness situations.  The device even allows for users to switch languages mid-instruction for translation of instructions to any other languages also on the EID.  In the United States, the device is sold with English and Spanish as the key default languages.

Think Safe has other patents that are in process and has already filed continuations on the existing patent that protects additional product developments and other unique features of the technology offering.  “You can expect to see more patents issued to Think Safe as the company matures and our product offerings mature and grow in popularity and change based upon customer needs or desires”, states Paula Wickham, Think Safe President.

Think Safe is committed to using technology to develop, manufacture and provide innovative products and solutions which improve training and access to CPR, First Aid, and other essential care during emergency situations, setting new standards for comprehensive emergency readiness and response.  We manufacture innovative products for first aid technology and are a major wholesaler for devices like our First Voice Emergency Instruction Device (EID) and all brands/makes/models of Automated External Defibrillators (AEDs), including services that make things easier for our dealers and customers.  Think Safe’s products are available under the First Voice product line brand name, ResQr, or RescueMate brand name in various countries today.  Think Safe primarily sells the First Voice product line through established distributors or dealers and continues to selectively add new dealers, based upon geographic area or industry focus of the dealer.

Check out our http://www.think-safe.com or http://www.firstvoice.us websites for more information on the products outlined on this blog post or other products and services developed by Think Safe to include: First Voice AED online web-based program management software and First Voice Compliance Management System Software (SaaS offerings);  First Voice AED program medical oversight services;  First Voice or American Heart Association First aid & CPR training (online Elearning, blended learning, or in-person instruction); and other safety-related products and services.

Think Safe won a SAXCIES award for "Best New Safety Product" for the Emergency Instruction Device (EID) invention

Think Safe won a SAXCIES award for “Best New Safety Product” for the Emergency Instruction Device (EID) invention

For more information on the Think Safe EID, check out the product on our website or fill out the form below!


Starry Elementary receives lifesaving donation of Automated External Defibrillator (AED)

May 1, 2014

Marion, IA- April 29, 2014- The students of Starry Elementary School in Marion, Iowa are celebrating the addition of an Automated External Defibrillator (AED) device to their school. This addition was made possible from a donation made by the children of Jean Ross, a former nurse and friend of the Marion Independent School District.

Jean Ross during her nursing years at Marion Independent School District

Jean Ross during her nursing years at Marion Independent School District

Ross attended the event with her husband, George, and children, Patricia (Karl) Knutson, Nancy (Donald) Christensen, and David (Cheryl) Ross. Not able to attend the celebration was another son, Lachlan (Mary) Ross from North Carolina. The AED funding was provided by the family of Ross to celebrate Ross’s dedication and commitment to children. Starry Elementary has placed a special plaque to honor Ross next to the AED storage cabinet. Ross provided a simple yet appropriate statement during the event, “School is about the kids and it is great the Ross family can do something to help these kids [at Starry Elementary].”

AED devices are a critical component in increasing survival rates among sudden cardiac arrest (SCA) victims. SCA is the leading killer in the United States and does not discriminate based on age. An estimated 5,000-7,000 students under the age of 21 die as a result of SCA every year in the United States. Most of these students never had prior symptoms and were unaware of any heart-related medical condition that may have resulted in SCA. SCA annually claims over 300,000 lives alone in the United States; more people every year are killed by SCA than by cancer and strokes combined. The key to fighting SCA is defibrillation (use of an AED) within a very short period of time from the onset of SCA. The statistics show that for every minute that passes there is a 10% decreased chance of survival. AEDs allow for defibrillation during the initial minutes after 9-1-1 EMS has been called, those critical early minutes make all the difference between life and death during SCA events.

Nancy Alderdyce, Head Nurse for Marion Independent School District has been extremely proactive in preparing the schools for SCA emergencies. Each building in the Marion school district is now equipped with an AED device due to the hard work and diligence of Alderdyce, and several other key people. In addition, staff training for the AED devices are handling lifesaving events remains a focal point for Nancy and the school district. These devices are especially important in the Marion Independent School District because they have certain at-risk students that may have more need for an AED due to diagnosed heart conditions. Usually students that die from SCA have not been pre-diagnosed and suddenly collapse and die. The AED also helps to offset the risk of death from a student not being diagnosed in the past with any heart condition.

The device Starry Elementary is receiving is a Heartsine Samaritan 350P AED. This AED is part of a pay-it-forward program called “Forward Hearts Program”, where any person saved or responder who saves an SCA victim with a Heartsine AED gets to donate a Heartsine Samaritan AED to the organization of their choice.

The Heartsine AED was sourced from a well-established industry integrator and wholesaler, Think Safe. Think Safe has been providing life saving equipment and training for over 10 years, all over the world, and is headquartered in the Cedar Rapids metro area. Think Safe Inc. is an innovator in the first aid industry and holds various proprietary patents as a manufacturer of First Voice first aid hardware and software products.

 

Nancy Alderdyce installing the AED with Jean and George Ross at Starry Elementary

Nancy Alderdyce installing the AED with Jean and George Ross at Starry Elementary

Think Safe has seen the value of implementing AEDs and the lives that can be saved by them. New lifesaving stories can be regularly viewed on their website or Think Safe Blog. Think Safe is dedicated to the fight against SCA and gladly offers AED grants or contributing donations to help offset the costs of lifesaving devices. “Every school, like Starry Elementary, should have or should make plans on how to purchase an AED. It is a rewarding experience when a survivor gets to tell their story and pay-it-forward and is certainly a better outcome than being one of the 300,000 victims. The family of Jean Ross should feel really good about what they have contributed to this school in honor of their mother; this gift will keep giving for decades into the future,” states Think Safe President, Paula Wickham.

Jean Ross, her family, and members of Marion School District staff posing with their new AED

Jean Ross, her family, and members of Marion School District staff posing with their new AED


AED UPDATE: 2020 FDA Approved AEDs

March 3, 2014

Click here to see

if your AED is FDA Approved




Did you know about this Philips AED

Recall?



Philips has recently issued a recall on their HeartStart Home and OnSite (HS1) AEDs.

Affected Devices :  Serial Number A13G-#####

If you have purchased a Philips device in 2013 or after,  please read the information below to see if you are affected. If you are affected contact Philips immediately for a replacement device at 1-800-263-3342 and select OPTION 5.  Live technical support is available Monday through Friday, 7:00AM to 5:00PM PST.  You can also leave a message 24 hours a day, seven days a week and a customer support representative will return your call promptly on the next business day.

Read the letter from Philips:

Philips Field Note 2014 FEB 10

Models Affected: M5066A and M5068A.  Affected Devices have Serial Number A13G-#####

Problem: Contact pins contaminated preventing a connection from pads cartridge to the AED.

Other AEDs under recall:

Recall Date: 01/01/2016
Title: 9131-001 Defibrillator Electrodes, Lot No. 141125-02
Units: Powerhear G3 9300A, 9300E, 9300p, 9390A, and 9390E AEDs
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 01/13/2012
Title: Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall.
Units: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs)
selected Powerheart models, 9300E, 9300P, 9390A, 9390E, 11,000 units worldwide.
Issue: Cardiac Science is conducting a voluntary recall of a limited number of automated external defibrillators (AEDs) manufactured between July 1, 2011 and December 30, 2011. The affected AEDs contain a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy. This issue was detected at the Cardiac Science factory through our standard quality control processes. We have no reports of this issue impacting a rescue. This action is being conducted with the knowledge of the appropriate Regulatory Agencies.
Fix: enter serial number, if on the list contact Cardiac Science and have repaired at no cost.
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 06/29/2010
Title: Mandatory Software Update for Field Correction: AED resistor and AED relay
Does your unit need to have the 11/13/09 corrective action?
Fix: enter serial number, if on the list download and install the software update
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/03/2010
Title: Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall
Fix: If on the list, remove from service immediately. CS will replace the AED
Need help with recalls for your device? Contact Think Safe!
Recall Date: 11/13/2009
Title: Voluntary Medical Device Correction: AED resistor and AED relay
Fix: Install mandatory software update on all models
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/09/2009
Title: Factory-Testing Corrective Action
Fix: If on the list, send unit to CS for testing
Need help with recalls for your device? Contact Think Safe!
Recall Date: 12/03/2014
Title: PadPro and R2 Multi-Function Defibrillation Electrodes because they will not work with Philips FR3 and FRx AEDs.
Units:

 

  • Adult Radiotransparent Electrode
    • Catalog Number: 2001H, 2001H-C, 2001H-PC, 2516H, 2516H-PC
  • Pediatric Radiotranslucent Electrode
    • Catalog Number: 2603H
  • Mini Pediatric Radiotranslucent Electrode
    • Catalog Number: 2602H
  • Pediatric R2 Multifunction Electrode
    • Catalog Number: 3115-1750
  • R2 Multifunction Electrode
    • Catalog Number: 3115-1751
Issue: Electrodes will not work with Philips FR3 and FRx AEDs. Philips made changes to the connector design of their FR3 and FRx AEDs. Because of these changes, the CONMED electrodes will no longer work with these AEDs. The FRx AED requires electrode pads be connected to the device before it is used. The AED will make a continuous alarm chirp to alert the user that the correct pads are not connected. The FR3 does not require electrode pads to be pre-connected. Users will not know that the pads do not work until they try to use the AED. This may result in a delay in delivering the electrical therapy needed to revive a patient. Delay in therapy could result in serious injury or death.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 03/14/2011
Title: Defibtech LLC, Lifeline and ReviveR AEDs: Software Defect May Cancel Shock
Units: Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR.
65,885 AEDs distributed in the United States are subject to this recall.
Issue: AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient.
Fix: Customers can check the nine-digit serial number on the back of their AED against the list published by Defibtech to see if their devices are affected.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 05/21/2010
Title: Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED
Units: DBP-2800 Battery Pack for the Defibtech ReviveR AED
Fix: Contact Defibtech for correction
Need help with recalls for your device? Contact Think Safe!
Recall Date: 09/12/2012
Title: HeartSine Samaritan 300/300P PAD Voluntary Recall
Units: HeartSine Samaritan 300/300P PADs, if your unit was recalled you will have received a letter directly from HeartSine.
Units affected are:
0400000501 – 0700032917
08A00035000 – 10A0070753
10C00200000 – 10C00210106
Issue: Off/On issue, battery management software issue.
Fix: Contact Think Safe 319-377-5125, 8 AM through 5 PM CST, Monday through Friday
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/16/2018
Title: Field Action for R92 Resistor Issue
Units: A limited number of Philips HeartStart Home and OnSite (HS1) and Philips FRx units are affected by this action.
Serial numbers
of all affected devices.
Home/Onsite: A02I-xxxxx – A13B-xxxxx
FRx: B04L-xxxxx – B13B-xxxxx
Issue: The issue affects certain HS1 (OnSite) and FRx defibrillators, which contain a component called a
resistor that, under extremely rare circumstances, may fail when high voltage is applied. In all
instances of resistor failure, the AED will initially communicate the failure by emitting a pattern
of triple chirps.
Fix: If your device is part of this notification and is still under warranty, customers may choose to receive a refurbished exchange unit at no cost If a device is no longer under warranty or if customers wish to purchase a newer model
replacement for their present AED. Philips is offering trade-in rebates, ranging from $50 to $625,
depending on the age and model of the affected AED. To request a warranty exchange unit or a
trade-in rebate, or to obtain additional information, customers should contact Think Safe at 888-473-1777.
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/14/2018
Title: HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs Recall
Units: Onsite (A13A-xxxxx or A13B-xxxxx) and Frx Automated External Defibrillators (B04L-xxxxx through B13B-xxxxx)
Issue: Philips HeartStart FRx, HeartStart OnSite, or HeartStart Home automated external defibrillators (AEDs)
manufactured between 2002 and 2013. Philips is voluntarily issuing this recall notification due to
awareness of isolated failures with one of the device’s electrical components (a resistor).
Fix: Contact Think Safe 319-377-5125, 8 AM through 5 PM CST, Monday through Friday
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/09/2018
Title: HeartStart MRx Defibrillators Recall
Units: Model/Item numbers: M3535A, M3536A
Issue: Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device’s Gas Discharge Tube (GDT). The GDT has micro cracks which allows internal gasses to escape and causes the tubes to not function as expected. This also permits an electrical current surge to cross the device’s designated resistors, which will damage the resistors and prevent the device from working while in automated external defibrillator (AED) mode.

 

As a result of this GDT defect, the HeartStart MRx may fail at any time, including when delivering repeated shocks in AED mode, or during the periodic Operational Check outlined in the device’s Instructions for Use. If the device is used in AED mode after failure, the device will not deliver patient therapy. Continued use of the device in AED mode after failure may lead to serious patient injury or death.

Need help with recalls for your device? Contact Think Safe!
Recall Date: 2/14/2014
Title: Feild Safety Notice: Contact Pin Contamination
Units: A limited number of Philips HeartStart Home and OnSite (HS1) models M5066A
and M5068A are affected by this action. Philips has identified the serial numbers
of all affected devices.
Issue: In a limited number of HeartStart Home and OnSite (HS1) AEDs, one or both
contact pins may be contaminated by residue from the soldering process. This
contamination could prevent an adequate connection between the pads cartridge
and the AED.
Fix: If you are have an affected device, please contact Philips for a replacement AED at 1-800-263-3342 and select option 5. Live technical support is available
Monday through Friday, 7:00AM to 5:00PM PST. You can also leave a message
24 hours a day, seven days a week; a customer support representative will
return your call promptly on the next business day.
Please keep your AED in service until you receive a replacement if there are no
alternative defibrillators readily available.
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 12/28/2012
Title: Philips HeartStart FR2+ defibrillator discontinuance
Units: FR2+
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/30/2012
Title: AED Maintenance Information
Issue: Philips wanted to inform FRx and OnSite HeartStart AED owners of potentially misunderstood alerts from their AEDs.
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 06/02/2010
Title: Voluntary recall: Specific Philips HeartStart HS1 and FRx Defibrillators
Units: HS1 (models M5066A and M5068A) and FRx
(model 861304) automated external defibrillators. The units affected by the recall
were manufactured by Philips in March 2010.
Fix: Perform serial number look up on company website, company will direct further if
your unit is affected.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 03/20/2020
Title: 2020 Component Wear that prevents patient Connection
Units: LIFEPAK 500
Issue: LIFEPAK 500 AEDs in high-use enviroments (Emergency Medical Services) may ot detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. Wear-through of the connector exposes base metal on which an oxide layer may form result in the device not recognizing a patient is connected. When the circumstance arises, the device will provide the user the “CONNECT ELECTRODES” message.
Fix: Replace AED with a FDA approved device.
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/27/2017
Title: Recalls Defibrillation Electrodes Due to Incorrect Placement Instructions for Infants Depicted on Artwork
Units: Model/Item Numbers: 11101-000016 and 11101-000017
Lot codes: 713609, 717912, 713904, 718033, 715008, 719323, 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823, 46078012
Manufacturing Dates: April 27, 2017 to August 10, 2017
Distribution Dates: May 30, 2017 to September 4, 2017
Devices Recalled in the U.S.: 7,973 units nationwide
Issue: Physio-Control Inc. is recalling infant/child defibrillation electrodes because the artwork on the pads within the packaging shows incorrect placement instructions for infants. There is no issue with the performance or function of the defibrillation electrodes. However, incorrect placement of the electrodes on an infant may result in failure to deliver an effective shock to an infant in cardiac arrest. A delay in therapy could result in serious injury and/or death.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 01/13/2017
Title: LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment.
Units: Lifepak 1000
Issue: LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment.
Fix: Customers are also being advised to implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices. The removal and reinstallation of the battery will clean the contacts of oxidation and will reduce the likelihood of this issue from occurring. Physio-Control will be initiating a hardware device correction for all affected LIFEPAK 1000 devices and the company will contact customers to schedule device corrections once the hardware correction is ready for implementation. The company will provide customers with updated information regarding the timing for this device correction at the website URL shown below, when it is available.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 07/19/2013
Title: 2013 class 2 recall of Lifepak 500 AED (all parties contacted so no remaining devices left to be upgraded)
Units: LIFEPAK 500 PART NUMBERS: 3011790-001568, 3011790-001574, 3011790-001627, 3011790-001634, and 3011790-001650.
Issue: The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 04/10/2013
Title: 2013 CR Plus and Express AED recall: (over 130,000 AEDs affected)
Units: LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part’s numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006.
Issue: LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 07/ 26/2011
Title: 2011 Lifepak 500 recall:
Units: LIFEPAK 500
Issue: The potential reliability issue is the result of a design characteristic of a SRAM (Static Random Access Memory) electronic component on the main printed circuit board assembly.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 07/31/2009
Title: Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillators (AEDs)
Units: Physio-Control LIFEPAK CR PLUS AEDs with the serial numbers below are affected by this recall.
Serial Numbers:

37026963, 37026983, 37026984, 37026997, 37027002,37027008,
37027039, 37027040, 37027049, 37027053,
37027063, 37027065,
37027066, 37027070, 37027071, 37027073, 37027075, 37027090,
37027099, 37027105
37027122, 37027197, 37027529, 37027569,
37031393,
37037850, 37037893, 37037986, 37038002, 37038211,
37038365, 37135986, 37154526, 37154638
Issue: An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.
Fix: Contact Physio-Control Customer Care
1-800-442-1142, 6 AM through 4 PM Pacific Time
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/30/2008
Title: CR Plus 2008 recall:
Units: LIFEPAK CR Plus
Issue: The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/30/2008
Title: 2008 Lifepak Express recall:
Units: LIFEPAK Express
Issue: The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 08/04/2007
Title: Lifepak 500 – 2007 recall
Units: biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)
Issue: Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 06/21/2007
Title: CR Plus – 2007 recall
Units: LIFEPAK CR Plus
Issue: Premature battery depletion due to electrical component failure
Need help with recalls for your device? Contact Think Safe!
Recall Date: 06/21/2007
Title: Lifepak Express – 2007 recall
Units: LIFEPAK EXPRESS defibrillator
Issue: Premature battery depletion due to electrical component failure
Need help with recalls for your device? Contact Think Safe!
Recall Date: 03/29/2007
Title: CR Plus – 2007 (march) recall
Units: LIFEPAK CR Plus
Issue: LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/23/2006
Title: CR Plus – 2006 recall
Units: LIFEPAK CR Plus
Issue: One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/22/2006
Title: Lifepak 500 – 2006 recall
Units: LIFEPAK 500
Issue: Component leads may have intermittent connection to the printed circuit board assembly pads – which could render the device inoperative.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/19/2005
Title: Lifepak 500 – 2005 recall (cases)
Units: a) Hard shell carry case for the Lifepak 500 AED.
Catalog number 3005384-000 through 002,
Recall # Z-0004-06;
b) Hard shell carry case for the Lifepak CR Plus.
Catalog number 3201582-000 through –002,
Recall # Z-0005-06
Issue: Some hard shell carry case for Lifepak 500 and Lifepak CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landing or mountain descent).
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/04/2005
Title: Lifepak CR Plus – 2005 recall (cases)
Units: Hard shell carry case for the LIFEPAK CR Plus.
Issue: Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).
Fix: On 7/12/05 the firm issued a letter to customers instructing the customers to inspect the cases for blocked vent. If the customer noted that the vent was blocked, to contact the firm for a replacement case. The firm provided response cards for the customers to return stating they had inspected their units.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 03/10/2005
Title: Lifepak 500 2005 recalls
Units: LIFEPAK 500
Serial numbers – various, noncontiguous Part numbers – 3005400-XXX, D3005400-XXX, U3005400-XXX
Issue: Potential to not detect patients at the low end of the patient impedance range.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/03/2005
Title: Certain Medtronic LIFEPAK 500 Automated External Defibrillators
Class 1 Recall
Units: LIFEPAK 500 automated external defibrillators (AEDs), part numbers 3005400-XXX, D3005400-XXX and U3005400-XXX. This action affects 1,924 devices. All were manufactured in 1997.
Issue: The affected AEDs may display a “Connect Electrodes” message and then will not defibrillate the patient, even when the electrodes are properly connected.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 07/20/2004
Title: Lifepak 500 – 2004 recalls
Units: LIFEPAK 500
Issue: Potential for batteries to malfunction due to battery cell rupture.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 06/12/2003
Title: Lifepak CR Plus – 2003 recall
Units: LIFEPAK CR Plus
All serial numbers below 31058753
Issue: Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
Need help with recalls for your device? Contact Think Safe!
Recall Date:
Title: Lifepak Express – 2006 recall
Units: LIFEPAK EXPRESS
Part number 3202177-00 through -002 Serial numbers listed above with the CR Plus
Issue: One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
Need help with recalls for your device? Contact Think Safe!
Recall Date:
Title: 2008 CR Plus recall:
Units: LIFEPAK CR Plus
Issue: This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device.
Need help with recalls for your device? Contact Think Safe!
 
Title: Welch Allyn AED 10 Recall Information
Units: Welch Allyn AED10 or MRL JumpStart defibrillator
* Part numbers 970300x, 970302x, 970308x, 970309x, 970310x, 970311x, where “x” specifies the language as English, Dutch, Danish, Chinese, French, German, Italian, Polish, Spanish, or European English
Issue: Low Energy Shock, Electromagnetic Noise Interference, Unexpected Shutdown During Use, Blown Fuse, Loss of Voice Prompts Shutdown in Cold Temperatures
Fix: Contact Think-Safe (888)473-1777
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/12/2009
Title: ZOLL Medical Corporation, ZOLL AED Plus Defibrillator, Class 1 Recall
Units: ZOLL AED Plus Defibrillator, Class 1 Recall Units Recalled: This product was manufactured from May, 2004 through February, 2009 and distributed from May, 2004 through February 9, 2009.
Issue: The AED failed to deliver the defibrillation energy.
Fix: The company sent their distributors and customers an initial recall letter on February 12, 2009 by certified mail. This letter instructed customers to replace their batteries every three years. The company then sent their distributors and customers a follow-up recall letter on March 31, 2009 by certified mail. This letter instructed customers to download new software for their devices and to remove any battery replacement reminder labels.
Need help with recalls for your device? Contact Think Safe!


If you would like to search for recalls that may be related to your AED within the US FDA database for “Medical Device Recalls”.

Please click here and type in your AED brand name or model in the fields provided.

More Information

If you need more information or want FREE assistance with your AED recall upgrade contact us on the form below and we are happy to help you with getting up to date! 

You can also call us at 888-473-1777 or

email us at info@think-safe.com.


AED (Automated External Defibrillator) Battery Recycle Program Offers Big Savings!

February 27, 2014

How much battery life do you have left on your Automated External Defibrillator (AED) Battery? Have you checked the install date or expiry date lately?

Think Safe can recycle your old battery from ANY AED, and we even PAY YOU for certain battery brands/models! All you have to do is call us, get a recycle program shipment packaging # assigned, and ship us your batteries for CASH OR CREDIT!

Why not call us to confirm how much you get money back on expired batteries?  Why not also check out our consumables (battery/pad/electrode) pricing?  We believe in providing the BEST PRICING on replacement supplies for your AED!    Keep reading for more details on how to recycle your battery and get the best deals!

Get paid for recycling batteries from these models:

Cardiac Science
Powerheart AED (9200RD/9210RD)
-Batteries discontinued. *Check on battery recycling programs to extend the life of your AED. Email us for more information.
Powerheart AED
Firstsave AED (9200D/9210D)
-Batteries discontinued. *Check on battery recycling programs to extend the life of your AED. Email us for more information.
Firstsave AED
Firstsave AED G3 (9300C-001)-Batteries discontinued. *Check on battery recycling programs to extend the life of your AED. Email us for more information.
Medtronic/Physio-Control
Medtronic/Physio-Control LifePak 500 (Catalog numbers 99401-001083, 99401-001085, 99401-001087 and 99401-001089)
-Batteries and pads- call for deadline information or Email us.**Check on battery recycling programs to extend the life of your AED. Email us for more information.
Owner manual
LIFEPAK 500 Nonrechargeable lithium sulfur dioxide (LiSO2) or lithium manganese dioxide (LiMnO2)battery pak.  *Check on battery recycling programs to extend the life of your AED. Email us for more information.
Philips
Heartstart FR2+ AED (M3860A/ M3861A)-Batteries and Pads call for deadline information or Email us.**Check on battery recycling programs to extend the life of your AED. Email us for more information.
Laerdal Heartstart FR2+ (M3840A/M3841A)
-Batteries and Pads call for deadline information or Email us.**Check on battery recycling programs to extend the life of your AED. Email us for more information.
Philips HeartStart
Forerunner AED or FR2
*-Batteries and Pads call for deadline information or Email us.**Check on battery recycling programs to extend the life of your AED. Email us for more information.

Also – get paid or earn a credit to recycle your: 
Philips:  FRx, Onsite, HeartStart batteriesBIG SAVINGS over the life of the AED are realized when you take advantage of this AED recycling program!

DO YOU Want THE BEST PRICING ON REPLACEMENT BATTERIES for your AED?  Save Money. No HasslesBe an AED Program HeroPricing is 1/2 or LESS of what normal prices are!  Full warranty batteries! Contact us at 319-377-5125 or fill out the form below to get more information!

We are here to help you with your AED program needs!  Fill out the form below to find out how to get $$$$$$$$ or earn future purchases credit per battery sent to Think Safe!


AEDs: Use by Hospitals, Nursing Homes, and Healthcare Providers

February 26, 2014

samaritan PAD with lights

Heartsine Samaritan AED

Just what is the standard or duty to provide care of healthcare, long-term care or elderly care providers for Automated External Defibrillators (AEDs)?

From my consistent research and study of the AED industry, the standard appears to be that many nursing homes, elderly housing complexes or assisted living facilities still do not have an AED policy or program.   In 2007 a summary study within the industry showed:

http://www.jamda.com/article/S1525-8610%2807%2900207-1/abstract

Contrarily, here is an Ohio-based Midwest article on AEDs & some facilities who have decided to implement AED programs:  http://www.redorbit.com/news/health/358076/many_nursing_homes_lack_device_to_restart_heart_portable_defibrillators/

Now, not taken into consideration is the question regarding “duty to provide care” – and what is really the up-to-date 2014 standard to provide care as it relates to AEDs or CPR in these facilities?

*  Are there any industry mandates taking place? What is the healthcare industry doing about AEDs?

*  What are the trends for DNR orders or Attempted CPR- are the number of DNR orders going up or down as a % of population being admitted to healthcare facilities?  Should nursing homes or long-term care facilities have solid AED programs in place due to a decreasing % of DNR orders and more patient preferences to attempt CPR?

In January 2010 there was a great article I read that showed how UCLA is implementing AED programs across their system, due to the improvement in SCA survival they offer. UCLA Article

Nursing Studies Show AEDs improve SCA response times (this is an additional Nurse.com article on SCA & AEDs in the industry)

I have also read many articles/studies in recent years on in-hospital SCA survival versus out-of-hospital survival and perhaps UCLA is trying to improve SCA survival and change the statistics, which show IN-HOSPITAL survival is lower than OUT-OF-HOSPITAL per many studies.  The above link shows the obstacles facing nurses and staff and why AEDs may be a welcome addition to healthcare facilities.

Regarding long-term and elderly facility industry practices such as DNR advanced directives

President, Think Safe Inc

are followed.  But, methods for identifying CPR status need improvement to enable accurate identification and prompt resuscitation of residents who want CPR:

http://www.gnjournal.com/article/S0197-4572%2898%2990117-3/abstract

It is known that ACPR is infrequently performed in long-term care setting and is rarely successful (successful being defined as admission to the hospital alive).  Survival (defined as discharge from the hospital) is also rare but survival does occur though. All nursing homes are not required to offer ACPR and many nursing homes in the United States, as well as in other parts of the world, do not offer ACPR.

In my assessment from my research, agencies such as the American Bar Association’s Commission on Law & Aging show that about two-thirds (2/3) of the adult population does not have an advanced directive or DNR.  I could not find any recent studies to answer my DNR questions on DNR preferences.

Recent mandates or pending mandates and “encouraged use” Bills have passed in recent years in the following states that are for assisted living facilities or long-term and medical facilities:  Texas, New Jersey, New York, Nevada, Florida and others.

Perhaps it will some day become an expectation for all long-term facilities to have an AED and perform CPR but for now, it appears that each facility has to make their own decision but for sure they should consider their state’s legislation or pending legislation as it affects licensing for their facility.

One excerpt of a study states, “Surveys have shown that many elderly in different parts of the world want to be resuscitated, but may lack knowledge about the specifics of cardiopulmonary resuscitation (CPR). Data from countries other than the US is limited, but differences in physician and patient opinions by nationality regarding CPR do exist.”  In the essence of observing the opinions of those elderly that do want to be resuscitated – perhaps there will be some marketing advantage to employ by organizations that implement AED programs.

For a summary of up-to-date Nursing Home laws and examples of corporate position statements regarding AED programs, complete the following form!


4 Steps to Take in an Emergency Situation for Caregivers

February 19, 2014

Here are 4 simple steps you’ll need to take when you find yourself in an emergency situation as a caregiver with a responsive person. Practicing these will help you know exactly what you need to do in an emergency.

4 Steps to Take in an Emergency Situation

Keeping your wits about you will be key, should an emergency arise. Practice these steps so that you’ll know exactly what to do in an emergency situation with a responsive person:

1. Assess the situation (S.A.M.P.L.E.). Answer some questions to get a better understanding of the event, and so you can relay that to emergency rescue when they arrive. Is your loved one conscious and breathing? If they are not, call 9-1-1 immediately and begin CPR compressions.  If they are conscious and responsive, look for:

(S)igns & Symptoms: What do you notice for deformities, open wounds, tenderness, swelling, if any? Do you notice any sweating, anxiety, rapid breathing?

(A)llergies: Do they have any? 

(M)edical Conditions or medications being taken or when were they last taken?

(P)rior problems they have had? Prior health history or medical emergencies?

(L)ast food and drink they had?

(E)vents: What were they doing just prior to the emergency? Did you or they observe anything odd or different?

Other questions: Was there a complaint of pain or anything else relevant? What is different or unusual about your loved one? Observe and compile as much as you can before calling 911.FA-Card-Front

2. Call 911. Do this when you have the even slightest hint that your loved one is facing a life-threatening emergency. Do not attempt to take anyone with a potentially serious problem to the hospital yourself. Rather, 911 should be called immediately. It’s crucial to accurately describe the situation and speak slowly and clearly when talking with the 911 operator.

3. Loosen any tight clothing. Make sure your loved one has nothing constricting the airways, like a restrictive shirt or tie, and keep them in a comfortable position while you wait for help.

4. Comfort and communicate. Talk to your loved one until 911 arrives, but don’t encourage the victim to talk. You want them to be as calm as possible until emergency rescue arrives. Take slow, deep breaths to help yourself stay calm as well.

You don’t have to be intimidated by the potential for an emergency. When one happens it may seem frightening, but the time you take to be prepared can make the difference between life and death.

Whether you are a stay-at-home mom, caregiver to your parents, office executive, or a blue-collar worker, Think Safe has innovative emergency first aid tools and training that can be customized to fit your needs. Check us out online or call our experts today at 888-473-1777!

For a FREE first aid preparedness training course, contact us today!

Make it a great day!

For a copy of a FREE resource card, fill out the form below!

*Thanks to the following source: Linda Foster, MA at CarePages for some of the above content.

Gazette Recognizes American Heart Month

February 18, 2014

The Cedar Rapids Gazette is getting involved in American Hearth Month with their special educational section in Sunday’s paper. This section included multiple articles on how to be heart healthy, including an article on the importance of learning CPR and AED training. Check out the article below or click here to read it on the Gazette’s page.

Empower yourself: Learn CPR/AED

By Anne Kapler
The Gazette

More than 92 percent of people who suffer sudden cardiac arrest outside the hospital die.Teen Girl Practices CPR

If more people had CPR and AED training, that statistic could change.

According to the American Heart Association, effective bystander CPR provided immediately after sudden cardiac arrest can double or triple a victim’s chance of survival. The victim’s chances of survival increases when defibrillation from an AED (automated external defibrillator) occurs within the first three minutes after sudden cardiac arrest; for every minute that passes from collapse to defibrillation, survival decreases seven to ten percent.

“The majority of arrests do not occur in hospital in front of us, they occur at home with loved ones, or in the mall or in some other place out in the community,” says Carol Fridal, a registered nurse in the emergency department at Unity Point Health-St. Luke’s who’s also trained as an American Heart Association Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) instructor. “Those first minutes provide the greatest chance of having the patient survive. The response time in Cedar Rapids is great, but every minute counts when it comes to your heart. Recognizing the situation, calling for help (911), starting CPR and getting an AED are the key things to increase survival.”

CPR has been around for more than 50 years. If you have not been trained in CPR or are worried about giving mouth-to-mouth to a stranger, you can do chest compressions only, known as Hands-Only CPR: Call 911, and push hard and fast in the center of the chest to the beat of the Bee Gee’s “Stayin’ Alive.” Full CPR training is available locally through the American Heart Association, hospitals, and agencies like the Red Cross and First Voice.

CPR keeps blood and oxygen circulating in the body until advanced medical help arrives. An AED can restart the heart, providing a better chance of survival. Today, AEDs are increasingly available communitywide — they’re in the public library and the mall, in schools, sports venues and churches, at the fairgrounds and in every police car in Linn County. Many CPR courses incorporate AED training.

“The frequency of seeing AEDs in the public has doubled, tripled, quadrupled in the last ten years,” Fridal says. A machine that delivers an electric shock to the heart may sound intimidating to the lay person, but Fridal says they are easy to use: “Once you open it up and turn it on, it tells you what to do every step of the way. Really, anybody can use one. But, ideally, we’d love to have everybody go through training — it gives you an opportunity to handle one and find out that it’s not so intimidating, and to feel more prepared in the event of an emergency.”

Fridal urges people to remember that cardiac arrest knows no age. It can strike anyone, at any time. Each year more than 300,000 adults and 7,000 children will be affected by sudden cardiac arrest. The best way to be prepared for an unexpected emergency — and help your loved ones — is to get trained on proper response techniques.

“The typical class is only about three hours,” she says. “And people are so empowered and excited that the time goes very quickly. I pray that nobody ever has to use CPR, but if they’re trained and they’re prepared, they can make a difference and save a life. What they do is just as important as what we do in the hospital.”

Heart Attack or Sudden Cardiac Arrest?

A heart attack occurs when a blocked artery prevents blood from reaching a section of the heart. Symptoms may be immediate and intense, or they may start slowly and persist for hours, days or weeks before the attack occurs. The heart usually does not stop beating during a heart attack. Still, don’t wait more than five minutes to call 911. It’s best to get to the emergency room right away.

Sudden cardiac arrest occurs suddenly and often without warning. It is triggered by an electrical malfunction in the heart that causes an irregular heartbeat. If someone is not breathing normally and is not moving or unconscious, call 911 immediately and begin CPR. If an AED is available, use it as soon as possible.

Most heart attacks do not lead to sudden cardiac arrest, but heart attacks are a common cause of sudden cardiac arrest.

Source: American Heart Association

This story originally appeared in The Gazette’s American Heart Month special section, published on Feb. 2, 2014.

Read more: http://thegazette.com/2014/02/03/empower-yourself-learn-cpraed/#ixzz2tEjgOCk5
For more information on our in person or online CPR & AED training classes, please fill out the form below or contact us at 319-377-5125!


AED Recall Information

February 14, 2014

Past records illustrate the significant number of recalls on AED devices. It is extremely important you stay updated on this information and check that your device is not affected. Look at the list below or click on the link to our website for more detailed information on these recalls.  This list may not be all inclusive; if you find or have an AED recall that is not mentioned, please send us that update via email!

Recall Date: 01/13/2012
Title: Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall.
Units: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs)
selected Powerheart models, 9300E, 9300P, 9390A, 9390E, 11,000 units worldwide.
Issue: Cardiac Science is conducting a voluntary recall of a limited number of automated external defibrillators (AEDs) manufactured between July 1, 2011 and December 30, 2011. The affected AEDs contain a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy. This issue was detected at the Cardiac Science factory through our standard quality control processes. We have no reports of this issue impacting a rescue. This action is being conducted with the knowledge of the appropriate Regulatory Agencies.
Fix: enter serial number, if on the list contact Cardiac Science and have repaired at no cost.
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 06/29/2010
Title: Mandatory Software Update for Field Correction: AED resistor and AED relay
Does your unit need to have the 11/13/09 corrective action?
Fix: enter serial number, if on the list download and install the software update
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/03/2010
Title: Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall
Fix: If on the list, remove from service immediately. CS will replace the AED
Need help with recalls for your device? Contact Think Safe!
Recall Date: 11/13/2009
Title: Voluntary Medical Device Correction: AED resistor and AED relay
Fix: Install mandatory software update on all models
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/09/2009
Title: Factory-Testing Corrective Action
Fix: If on the list, send unit to CS for testing
Need help with recalls for your device? Contact Think Safe!
Recall Date: 12/03/2014
Title: PadPro and R2 Multi-Function Defibrillation Electrodes because they will not work with Philips FR3 and FRx AEDs.
Units:

  • Adult Radiotransparent Electrode
    • Catalog Number: 2001H, 2001H-C, 2001H-PC, 2516H, 2516H-PC
  • Pediatric Radiotranslucent Electrode
    • Catalog Number: 2603H
  • Mini Pediatric Radiotranslucent Electrode
    • Catalog Number: 2602H
  • Pediatric R2 Multifunction Electrode
    • Catalog Number: 3115-1750
  • R2 Multifunction Electrode
    • Catalog Number: 3115-1751
Issue: Electrodes will not work with Philips FR3 and FRx AEDs. Philips made changes to the connector design of their FR3 and FRx AEDs. Because of these changes, the CONMED electrodes will no longer work with these AEDs. The FRx AED requires electrode pads be connected to the device before it is used. The AED will make a continuous alarm chirp to alert the user that the correct pads are not connected. The FR3 does not require electrode pads to be pre-connected. Users will not know that the pads do not work until they try to use the AED. This may result in a delay in delivering the electrical therapy needed to revive a patient. Delay in therapy could result in serious injury or death.
Need help with recalls for your device? Contact First Voice!
Recall Date: 03/14/2011
Title: Defibtech LLC, Lifeline and ReviveR AEDs: Software Defect May Cancel Shock
Units: Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR.
65,885 AEDs distributed in the United States are subject to this recall.
Issue: AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient.
Fix: Customers can check the nine-digit serial number on the back of their AED against the list published by Defibtech to see if their devices are affected.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 05/21/2010
Title: Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED
Units: DBP-2800 Battery Pack for the Defibtech ReviveR AED
Fix: Contact Defibtech for correction
Need help with recalls for your device? Contact Think Safe!
Recall Date: 09/12/2012
Title: HeartSine Samaritan 300/300P PAD Voluntary Recall
Units: HeartSine Samaritan 300/300P PADs, if your unit was recalled you will have received a letter directly from HeartSine.
Units affected are:
0400000501 – 0700032917
08A00035000 – 10A0070753
10C00200000 – 10C00210106
Issue: Off/On issue, battery management software issue.
Fix: Contact Think Safe 319-377-5125, 8 AM through 5 PM CST, Monday through Friday
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/27/2017
Title: Recalls Defibrillation Electrodes Due to Incorrect Placement Instructions for Infants Depicted on Artwork
Units: Model/Item Numbers: 11101-000016 and 11101-000017
Lot codes: 713609, 717912, 713904, 718033, 715008, 719323, 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823, 46078012
Manufacturing Dates: April 27, 2017 to August 10, 2017
Distribution Dates: May 30, 2017 to September 4, 2017
Devices Recalled in the U.S.: 7,973 units nationwide
Issue: Physio-Control Inc. is recalling infant/child defibrillation electrodes because the artwork on the pads within the packaging shows incorrect placement instructions for infants. There is no issue with the performance or function of the defibrillation electrodes. However, incorrect placement of the electrodes on an infant may result in failure to deliver an effective shock to an infant in cardiac arrest. A delay in therapy could result in serious injury and/or death.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 01/13/2017
Title: LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment.
Issue: The company has determined that this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. This condition can occur over time in LIFEPAK 1000 devices that are exposed to vibration and have a battery installed for long periods of time. This issue can potentially affect any LIFEPAK 1000 device, however customers with non-rechargeable batteries who do not routinely remove the battery for inspection, as indicated in the LIFEPAK 1000 Defibrillator Operating Instructions, are more susceptible to this issue.
Fix: Customers are also being advised to implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices. The removal and reinstallation of the battery will clean the contacts of oxidation and will reduce the likelihood of this issue from occurring. Physio-Control will be initiating a hardware device correction for all affected LIFEPAK 1000 devices and the company will contact customers to schedule device corrections once the hardware correction is ready for implementation. The company will provide customers with updated information regarding the timing for this device correction at the website URL shown below, when it is available.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 07/19/2013
Title: 2013 class 2 recall of Lifepak 500 AED (all parties contacted so no remaining devices left to be upgraded)
Units: LIFEPAK 500 PART NUMBERS: 3011790-001568, 3011790-001574, 3011790-001627, 3011790-001634, and 3011790-001650.
Issue: The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.
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Recall Date: 04/10/2013
Title: 2013 CR Plus and Express AED recall: (over 130,000 AEDs affected)
Units: LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part’s numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006.
Issue: LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.
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Recall Date: 07/ 26/2011
Title: 2011 Lifepak 500 recall:
Units: LIFEPAK 500
Issue: The potential reliability issue is the result of a design characteristic of a SRAM (Static Random Access Memory) electronic component on the main printed circuit board assembly.
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Recall Date: 07/31/2009
Title: Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillators (AEDs)
Units: Physio-Control LIFEPAK CR PLUS AEDs with the serial numbers below are affected by this recall.
Serial Numbers:
37026963, 37026983, 37026984, 37026997, 37027002,37027008,
37027039, 37027040, 37027049, 37027053,
37027063, 37027065,
37027066, 37027070, 37027071, 37027073, 37027075, 37027090,
37027099, 37027105
37027122, 37027197, 37027529, 37027569,
37031393,
37037850, 37037893, 37037986, 37038002, 37038211,
37038365, 37135986, 37154526, 37154638
Issue: An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.
Fix: Contact Physio-Control Customer Care
1-800-442-1142, 6 AM through 4 PM Pacific Time
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Recall Date: 10/30/2008
Title: CR Plus 2008 recall:
Units: LIFEPAK CR Plus
Issue: The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.
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Recall Date: 10/30/2008
Title: 2008 Lifepak Express recall:
Units: LIFEPAK Express
Issue: The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.
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Recall Date: 08/04/2007
Title: Lifepak 500 – 2007 recall
Units: biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)
Issue: Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.
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Recall Date: 06/21/2007
Title: Lifepak Express – 2007 recall
Units: LIFEPAK EXPRESS defibrillator
Issue: Premature battery depletion due to electrical component failure
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Recall Date: 06/21/2007
Title: CR Plus – 2007 recall
Units: LIFEPAK CR Plus
Issue: Premature battery depletion due to electrical component failure
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Recall Date: 03/29/2007
Title: CR Plus – 2007 (march) recall
Units: LIFEPAK CR Plus
Issue: LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement.
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Recall Date: 02/23/2006
Title: CR Plus – 2006 recall
Units: LIFEPAK CR Plus
Issue: One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
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Recall Date: 02/22/2006
Title: Lifepak 500 – 2006 recall
Units: LIFEPAK 500
Issue: Component leads may have intermittent connection to the printed circuit board assembly pads – which could render the device inoperative.
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Recall Date: 10/19/2005
Title: Lifepak 500 – 2005 recall (cases)
Units: a) Hard shell carry case for the Lifepak 500 AED.
Catalog number 3005384-000 through 002,
Recall # Z-0004-06;
b) Hard shell carry case for the Lifepak CR Plus.
Catalog number 3201582-000 through –002,
Recall # Z-0005-06
Issue: Some hard shell carry case for Lifepak 500 and Lifepak CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landing or mountain descent).
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Recall Date: 10/04/2005
Title: Lifepak CR Plus – 2005 recall (cases)
Units: Hard shell carry case for the LIFEPAK CR Plus.
Issue: Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).
Fix: On 7/12/05 the firm issued a letter to customers instructing the customers to inspect the cases for blocked vent. If the customer noted that the vent was blocked, to contact the firm for a replacement case. The firm provided response cards for the customers to return stating they had inspected their units.
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Recall Date: 03/10/2005
Title: Lifepak 500 2005 recalls
Units: LIFEPAK 500
Serial numbers – various, noncontiguous Part numbers – 3005400-XXX, D3005400-XXX, U3005400-XXX
Issue: Potential to not detect patients at the low end of the patient impedance range.
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Recall Date: 02/03/2005
Title: Certain Medtronic LIFEPAK 500 Automated External Defibrillators
Class 1 Recall
Units: LIFEPAK 500 automated external defibrillators (AEDs), part numbers 3005400-XXX, D3005400-XXX and U3005400-XXX. This action affects 1,924 devices. All were manufactured in 1997.
Issue: The affected AEDs may display a “Connect Electrodes” message and then will not defibrillate the patient, even when the electrodes are properly connected.
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Recall Date: 07/20/2004
Title: Lifepak 500 – 2004 recalls
Units: LIFEPAK 500
Issue: Potential for batteries to malfunction due to battery cell rupture.
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Recall Date: 06/12/2003
Title: Lifepak CR Plus – 2003 recall
Units: LIFEPAK CR Plus
All serial numbers below 31058753
Issue: Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
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Recall Date:
Title: Lifepak Express – 2006 recall
Units: LIFEPAK EXPRESS
Part number 3202177-00 through -002 Serial numbers listed above with the CR Plus
Issue: One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
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Recall Date:
Title: 2008 CR Plus recall:
Units: LIFEPAK CR Plus
Issue: This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device.
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Recall Date: 2/16/2018
Title: Field Action for R92 Resistor Issue
Units: A limited number of Philips HeartStart Home and OnSite (HS1) and Philips FRx units are affected by this action.
Serial numbers
of all affected devices.
Home/Onsite: A02I-xxxxx – A13B-xxxxx
FRx: B04L-xxxxx – B13B-xxxxx
Issue: The issue affects certain HS1 (OnSite) and FRx defibrillators, which contain a component called a
resistor that, under extremely rare circumstances, may fail when high voltage is applied. In all
instances of resistor failure, the AED will initially communicate the failure by emitting a pattern
of triple chirps.
Fix: If your device is part of this notification and is still under warranty, customers may choose to receive a refurbished exchange unit at no cost If a device is no longer under warranty or if customers wish to purchase a newer model
replacement for their present AED. Philips is offering trade-in rebates, ranging from $50 to $625,
depending on the age and model of the affected AED. To request a warranty exchange unit or a
trade-in rebate, or to obtain additional information, customers should contact Think Safe at 888-473-1777.
Alert Documentation
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Recall Date: 02/09/2018
Title: HeartStart MRx Defibrillators Recall
Units: Model/Item numbers: M3535A, M3536A
Issue: Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device’s Gas Discharge Tube (GDT). The GDT has micro cracks which allows internal gasses to escape and causes the tubes to not function as expected. This also permits an electrical current surge to cross the device’s designated resistors, which will damage the resistors and prevent the device from working while in automated external defibrillator (AED) mode.

As a result of this GDT defect, the HeartStart MRx may fail at any time, including when delivering repeated shocks in AED mode, or during the periodic Operational Check outlined in the device’s Instructions for Use. If the device is used in AED mode after failure, the device will not deliver patient therapy. Continued use of the device in AED mode after failure may lead to serious patient injury or death.

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Recall Date: 2/14/2014
Title: Feild Safety Notice: Contact Pin Contamination
Units: A limited number of Philips HeartStart Home and OnSite (HS1) models M5066A
and M5068A are affected by this action. Philips has identified the serial numbers
of all affected devices.
Issue: In a limited number of HeartStart Home and OnSite (HS1) AEDs, one or both
contact pins may be contaminated by residue from the soldering process. This
contamination could prevent an adequate connection between the pads cartridge
and the AED.
Fix: If you are have an affected device, please contact Philips for a replacement AED at 1-800-263-3342 and select option 5. Live technical support is available
Monday through Friday, 7:00AM to 5:00PM PST. You can also leave a message
24 hours a day, seven days a week; a customer support representative will
return your call promptly on the next business day.
Please keep your AED in service until you receive a replacement if there are no
alternative defibrillators readily available.
Alert Documentation
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Recall Date: 12/28/2012
Title: Philips HeartStart FR2+ defibrillator discontinuance
Units: FR2+
Alert Documentation
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Recall Date: 10/30/2012
Title: AED Maintenance Information
Issue: Philips wanted to inform FRx and OnSite HeartStart AED owners of potentially misunderstood alerts from their AEDs.
Alert Documentation
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Recall Date: 06/02/2010
Title: Voluntary recall: Specific Philips HeartStart HS1 and FRx Defibrillators
Units: HS1 (models M5066A and M5068A) and FRx
(model 861304) automated external defibrillators. The units affected by the recall
were manufactured by Philips in March 2010.
Fix: Perform serial number look up on company website, company will direct further if
your unit is affected.
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Recall Date: 02/25/2009
Title: Welch Allyn AED 10 Recall Information
Units: Welch Allyn AED10 or MRL JumpStart defibrillator
* Part numbers 970300x, 970302x, 970308x, 970309x, 970310x, 970311x, where “x” specifies the language as English, Dutch, Danish, Chinese, French, German, Italian, Polish, Spanish, or European English
Issue: Low Energy Shock, Electromagnetic Noise Interference, Unexpected Shutdown During Use, Blown Fuse, Loss of Voice Prompts Shutdown in Cold Temperatures
Fix: Contact Think-Safe (888)473-1777
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Recall Date: 02/12/2009
Title: ZOLL Medical Corporation, ZOLL AED Plus Defibrillator, Class 1 Recall
Units: ZOLL AED Plus Defibrillator, Class 1 Recall Units Recalled: This product was manufactured from May, 2004 through February, 2009 and distributed from May, 2004 through February 9, 2009.
Issue: The AED failed to deliver the defibrillation energy.
Fix: The company sent their distributors and customers an initial recall letter on February 12, 2009 by certified mail. This letter instructed customers to replace their batteries every three years. The company then sent their distributors and customers a follow-up recall letter on March 31, 2009 by certified mail. This letter instructed customers to download new software for their devices and to remove any battery replacement reminder labels.
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