Certain defibrillators manufactured by Philips Healthcare were recalled in 2012 due to internal electrical component failure. Now, over one year after the recalls, the FDA is warning patients still implanted with the devices that there is a high possibility they will fail in medical emergencies. If the heart skips a beat or is otherwise beating irregularly, cardiac defibrillators must send electrical shocks to restart normal rhythm. Defective defibrillator lawyers at Pintas & Mullins Law Firm warn that any type of electrical failure in these devices may result in cardiac arrest and death.
The defective Philips defibrillators included: the HeartStartFRx, HeartStart HS1 Home, and HeartStart HS1 OnSite, which were distributed between 2005 and 2012. The recall affected more than 700,000 devices, many of which are still implanted in patients, who are either unaware of the recall or are waiting for a replacement.
All patients currently implanted with a recalled Philips defibrillator are urged to contact Philips Healthcare immediately. The company will inspect the defibrillator and recommend a replacement. In a March 2011 warning letter, the FDA noted that Philips’ failure to correct defibrillator defects resulted in at least one fatality.
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During plant inspections, the FDA also found numerous quality assurance violations at Philips facilities, where it was discovered the company failed to establish procedures for reviewing patient complaints and failed to report adverse events to the FDA. In additional oversight efforts, the FDA announced in March 2013 that it will require AED manufacturers to submit premarket approval applications. These applications will focus specifically on the requirements necessary to ensure AEDs are safe and effective, further improving reliability.
AEDs save thousands of lives every year; they are portable electronic devices that automatically re-establish normal heart rhythms in patients experiencing cardiac arrhythmias. Due to defectively designed or manufactured devices, however, there have also been thousands of reports of AED failure, which can have dire consequences.
There have been over 1,000 adverse event reports over Philips defibrillators alone over the past few years. A spokesperson for the company stated that about 88% of implanted patients were contact regarding the defibrillator recalls. That leaves a substantial population of patients who remain unaware.
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If you or a loved one was injured due to a defective Philips Healthcare HeartStart Defibrillator, contact our firm immediately. Our team of defective product lawyers has extensive experience litigating bases on behalf of critically injured victims, and we have the resources to fight these cases nationwide. Our legal consultations are always free, and we never get paid unless we are successful on your behalf.