The U.S. Food and Drug Administration (FDA) warned that hundreds of thousands of Philips Healthcare defibrillators may fail in an emergency. The agency urged consumers to take additional precautions while awaiting replacement devices. The FDA issued a safety communication on HeartStart automated external defibrillator products made by Philips Medical Systems, part of the medical device unit of Koninklijke Philips NV. The advisory follows a massive recall of the devices initiated by Philips in 2012, covering around 700,000 devices.
The FDA warned that the devices may falter when needed most and fail to deliver a potentially life-saving shock during a cardiac emergency, but said that until a replacement could be obtained, even a potentially defective device was better than none at all. Steve Silverman, FDA Agency compliance chief, said in a statement:
The FDA advises keeping all recalled HeartStart AEDs in service until you obtain a replacement from Philips Healthcare or another AED manufacturer, even if the device indicates it has detected an error during a self-test. Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator.
The recalled devices include defibrillators made between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. The FDA’s announcement follows Philips’ Nov. 19 safety notice informing consumers that a faulty electrical component could prevent proper functioning of the defibrillators.
The FDA urged consumers to contact Philips immediately about a replacement, and to inspect their defibrillators and follow certain additional steps in the event of an emergency that requires use of the devices. The agency had previously warned Philips about the HeartStart defibrillators, saying in a March 2011 letter that the devices did not conform with FDA regulations and that Philips’ failure to correct defects had led to at least one fatality. The FDA said it had received 87 complaints about the products since January 2008, and outlined problems with the products:
The FDA reported that a defibrillator that failed to shock “a pulseless ventricular tachycardia” had led to a death. In 2009, the FDA warned that its inspectors had found multiple quality assurance violations at Philips’ Massachusetts plant. According to the agency, the company had failed to establish adequate procedures for reviewing complaints and did not report events that might have caused death or serious injury.
The most recent warning came as the FDA was pushing to tighten the approval process for emergency defibrillators in an effort to address widespread device failures during cardiac arrests. This was because of dozens of recalls and 45,000 cases in the past eight years in which defibrillators didn’t perform as intended. In a statement, the FDA said:
Each year, nearly 300,000 Americans collapse from sudden cardiac arrest. When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death. The FDA will continue to closely monitor all AED manufacturers’ quality system practices and manufacturing changes that have persistently contributed to recall and adverse events associated with AEDs.
Sources: Gavin Broady and Law360.com
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