Navigation Links
FDA Warns Users About Faulty Components in 14 External Defibrillator Models
Date:4/27/2010

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:  http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )

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

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191426.htm

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

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:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical ... the "Company"), which develops, markets and sells medical devices ... , signed a strategic cooperation agreement with Hongyuan ... "Hongyuan Supply Chain") on June 20, 2016, to develop ... the strategic cooperation agreement, Dehaier will leverage Hongyuan Supply ...
(Date:6/24/2016)... Belgium , June 24, 2016 ... the appointment of Dr. Edward Futcher ... Non-Executive Director, effective June 23, 2016.Dr. Futcher was ... Nominations and Governance Committees.  As a non-executive member ... independent expertise and strategic counsel to VolitionRx in ...
(Date:6/23/2016)... , June 23, 2016 Research ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, ... (Oral, Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is ... a CAGR of 6.1% in the forecast period 2016 ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension ... that it will receive two significant new grants to support its work to ... its 25th anniversary by recognizing patients, medical professionals and scientists for their work ...
(Date:6/24/2016)... ... ... Comfort Keepers® of San Diego, CA is excited to announce they are ... drive cancer patients to and from their cancer treatments. Comfort Keepers provides quality ... and ongoing independence. Getting to and from medical treatments is one of the ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB ... Decision Making in Emergency Medicine conference in Ponte Vedra Beach, FL. The awards ... in Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , “With ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... the Frederick area economy by obtaining investment capital for emerging technology companies. ... years that have already resulted in more than a million dollars of capital ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... human induced pluripotent stem (iPS) cells and other difficult to transfect cells, announces ... Medium. The PluriQ™ G9™ Gene Editing System is a complete system ...
Breaking Medicine News(10 mins):