The Food & Drug Administration is warning that about 280,000 external defibrillators around the world could malfunction due to a faulty component made by Cardiac Science Corp. (NSDQ:CSCX).
The FDA said the problem could cause the devices, designed to shock the heart back to beating after sudden cardiac arrest, to fail to deliver a shock.
Bothell, Wash.-based Cardiac Science issued a recall for its Powerheart and CardioVive models in November 2009, according to a press release. Since then the federal watchdog said it’s learned that Cardiac Science defibrillators marketed by Nihon Kohden and GE Healthcare have similar problems, according to the release.
The FDA said its review of a software update for two of the Powerheart defibrillators Cardiac Science put out in February 2010 and similar, upcoming offerings detects only some of the potential defects.
The problem affects 14 defibrillator models: Cardiac Science’s Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E models; its CardioVive 92531, 92532 and 92533 models; Nihon Kohden’s 9200G and 9231 models; and GE Healthcare’s GE Responder models 2019198 and 2023440.
The agency is recommending that the affected models be replaced by alternative devices in high-risk settings like hospitals and health clinics. If replacements aren’t readily available, the affected devices should still be used, the FDA said, because they still might work.
"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," according to the press release.
