A dangerous defective product alert from the U.S. Food and Drug Administration has warned that hundreds of thousands of Philips Healthcare defibrillators may fail in an emergency, and urged consumers to take additional precautions while awaiting replacement devices.
The agency 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 last year, 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. The recalled defective devices include defibrillators made between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. The FDA’s announcement comes on the heels of Philips’ Nov. 19 safety notice informing consumers that a faulty electrical component could prevent proper functioning of the defibrillators.
The agency has previously warned Philips about the HeartStart defibrillators, saying in a March 2011 letter that the devices did not conform with FDA regulations and that its failure to correct defects had led to at least one fatality. 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 warning comes as the FDA is pushing to tighten the approval process for emergency defibrillators in an effort to address widespread device failures during cardiac arrests, in the wake of dozens of recalls and 45,000 cases over the past eight years in which defibrillators didn’t perform as intended.