The FDA reported that 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. 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, Washington, 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, the FDA recommends continuing to use the affected devices if needed, because they may still deliver necessary therapy. The agency says 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 issued the notice so that “users can take the proper steps necessary to assure they have access to safe and effective defibrillators.”
Cardiac Science recalled its Powerheart and CardioVive models, manufactured between August 2003 and August 2009, on November 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 Great Britain.
While the company issued a recall late last year, the FDA has now learned that more models have the same problems. FDA officials say alternative devices should be used while Cardiac Science Corporation works on the problem. In the case of an emergency, however, the FDA says it’s better to use the potentially defective devices than not.
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.