Navigation Links
FDA Warns Users About Faulty Components in 14 External Defibrillator Models

Users should seek alternatives, if possible

SILVER SPRING, Md., April 27 /PRNewswire-USNewswire/ -- About 280,000 external defibrillators used worldwide in health care facilities, public places, or in the home may malfunction during attempts to rescue people in sudden cardiac arrest, the U.S. Food and Drug Administration warned today.

(Logo: )

Sudden cardiac arrest is a condition in which the heart suddenly and unexpectedly stops beating. When this happens, blood stops flowing to the brain and other vital organs, leading to death if not treated within minutes.

External defibrillators can send an electric shock to the heart to try to restore normal heart rhythm when sudden cardiac arrest occurs.

Faulty components in defibrillators manufactured by Cardiac Science Corp. of Bothell, Wash., may cause the devices to fail to properly deliver a shock. In addition to failure to deliver needed shocks, other problems with the affected models may include interruption of electrocardiography (ECG) analysis, failure to recognize electrode pads, and interference or background noise that makes the device unable to accurately analyze heart rhythm.

The 14 models, which include automated and semi-automated devices, are:

  • Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E
  • CardioVive models 92531, 92532 and 92533
  • Nihon Kohden models 9200G and 9231 and
  • GE Responder models 2019198 and 2023440.

The FDA recommends that hospitals, nursing homes and other high-risk settings obtain alternative external defibrillators and arrange for the repair or replacement of the affected defibrillators.

For all other users, including those who use the device at home or as part of public access programs, the FDA recommends using alternative external defibrillators if they are available, and arranging for the repair or replacement of the affected models.

If alternative external defibrillators are not immediately available, then FDA recommends continuing to use the affected devices if needed, because they may still deliver necessary therapy.  The potential benefits of using the available external defibrillators outweigh the risk of not using any of the affected external defibrillators or the risk of device failure.

"The FDA is issuing this notice so that users can take the proper steps necessary to assure they have access to safe and effective defibrillators," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health.

Cardiac Science recalled its Powerheart and CardioVive models, manufactured between August 2003 and August 2009, on Nov. 13, 2009. But the FDA has since learned that additional Cardiac Science models, two marketed under the Nihon Kohden name, and two marketed by GE Healthcare as GE Responder have similar problems.

Cardiac Science issued a software update for two of its Powerheart defibrillators in February 2010 and plans to issue similar software updates for other affected devices. However, FDA's review of the updated software indicates that the software detects some, but not all, identified defects.

Nihon Kohden is based in Tokyo, Japan. GE Healthcare is located in Britain.

For more information

Defective Cardiac Science Corporation Powerheart, CardioVive, Nihon Kohden, and GE Responder External Defibrillators:  Updated April 27, 2010

Media Inquiries: Karen Riley, 301-796-4674,

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. H.E.A.T. Warns Drivers, Auto Dealers of Continuing Trend in Unconventional Auto Crimes
2. Physicians Foundation Warns of Potential Impact From New Medicare Cuts Effective Today
3. FDA Warns Consumers about Counterfeit Alli
4. Toxic Chemical bisphenol A Still Not Banned By FDA; Schumer, Gillibrand Call for Ban; Govt Official Warns Public
5. Orkin Warns of Four Pests to Avoid this Fourth of July
6. New Federal Stem Cell Rules Would Hinder Existing Research, Consumer Group Warns
7. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Lebanon County Dairy
8. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Chester County Dairy
9. The Results are in: Users of BodyMedias Wearable Body-Monitoring Technology Lose 3 Times More Weight
10. Elekta VMAT Radiation Therapy Rapidly Gaining Users Worldwide as Technique Evolves
11. Horizon Therapeutics Presents Phase 3 Study Results Identifying Risk Factors for Ulcer Development Among NSAID Users
Post Your Comments:
(Date:11/26/2015)... 26, 2015 --> ... SyMRI to find optimal contrast weighting of MRI for ... has signed a research agreement with SyntheticMR in order to ... SyMRI, it is possible to generate multiple contrast images from ... patient has left, thus making it possible to both fine ...
(Date:11/26/2015)... SAN FRANCISCO , November 26, 2015 ... 1.82 billion by 2022, according to a new report by ... as Chronic Kidney Disease (CKD) which demands kidney transplantation is ... convenient and cost effective substitute for organ transplantation. --> ... 1.82 billion by 2022, according to a new report by ...
(Date:11/26/2015)... ) has ... Future Horizons and Growth Strategies in the ... Shares, Country Segment Forecasts, Competitive Intelligence, Emerging ... --> ) has announced the ... and Growth Strategies in the French Drugs ...
Breaking Medicine Technology:
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... ... offering factory direct sauna parts and accessories. , Sauna accessories help improve ... the bather’s style and personality. From basic styles for the purist looking for ...
(Date:11/25/2015)... (PRWEB) , ... November 26, 2015 , ... ... Union Commission (AUC), European Union (EU), ANDI Pan African Centres of Excellence, and ... Office in Nairobi (UNON) for the opening of the 5th African Network for ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... For the ... companies’ “ Two Organizations, One Beat ” campaign. The partnership between the two groups ... to aid in MAP International’s cause. , MAP International was founded in 1954 and ...
(Date:11/25/2015)... ... November 25, 2015 , ... Lakeview ... the country to celebrate their sobriety and show through pictures what a positive ... after” photos this Thanksgiving with the hashtag #FacesOfGratitude on their Facebook, Twitter, and ...
(Date:11/25/2015)... ... ... On November 25, 2015, officials of Narconon Arrowhead , the drug ... a new cutting edge recovery program that has been 50 years in the making. ... individuals with the purpose to free addicts from the symptoms and negative behaviors of ...
Breaking Medicine News(10 mins):