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:2/16/2017)... LOUIS , Feb. 16, 2017  Express Scripts (NASDAQ: ... of the World,s Most Admired Companies within the Health Care: Pharmacy ... be named one of the World,s Most Admired Companies," said ... driven by the commitment and passion of our 26,000 employees to ... we serve." ...
(Date:2/16/2017)... , Feb. 16, 2017  Prescription pain medications ... department visit are necessary for long-term opioid use to ... Feb. 16 th edition of The New ... "Emergency physicians see more patients in acute pain than ... Parker , MD, FACEP, president of the American College ...
(Date:2/16/2017)... 16, 2017   Spectralink Corporation , the ... healthcare, retail, manufacturing and hospitality industries, today announced ... and symbology support features of its PIVOT™:SC ... scanner. The study, conducted by The Tolly Group, ... two phones with dedicated hardware scanners. ...
Breaking Medicine Technology:
(Date:2/17/2017)... ... February 17, 2017 , ... ... its educational assistance management solution to the exhibit floor for the 2017 ... Fla. , From Feb. 19–23, 2017, more than 40,000 healthcare industry professionals ...
(Date:2/17/2017)... Verdes, CA (PRWEB) , ... February 17, 2017 ... ... emotional flow is Dr. Carol Francis' goals for each and every ... Conference, Dr. Carol Francis will demonstrate five different brainwave tools which help energize ...
(Date:2/17/2017)... ... February 17, 2017 , ... Qualis ... a finalist in the 8th Annual DecisionHealth Platinum Awards in recognition of its ... Health’s work is recognized across multiple award categories, highlighting four of the organization’s ...
(Date:2/17/2017)... , ... February 17, 2017 , ... ... fall 2017 season , Trinity Health and the U.S. Soccer Foundation announced today ... program in underserved communities. Soccer for Success, the Foundation’s soccer mentoring program, teaches ...
(Date:2/17/2017)... (PRWEB) , ... February 17, 2017 , ... ... clinical operations executives and focusing on all facets of clinical trial planning and ... management , patient engagement, and more. In addition, attendees stopping by Pharmica’s booth ...
Breaking Medicine News(10 mins):