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The Food and Drug Administration (FDA) is responsible for validating safety and efficacy for foods, drugs, and medical devices. In a release from December 3, they warn that certain Automatic External Defibrillators (AEDs) may not work when needed. In an important advisory, manufacturer Phillips Healthcare has recalled approximately 700,000 devices.
AEDs detect an individual’s heart rhythm, and if determined irregular, discharge a shock to initiate normal function until emergency medical personnel arrive. Most public facilities are required, or at least recommended, to have an AED on site for the safety of its patrons. The use of AEDs has saved countless at risk individuals from certain death.
Unfortunately, many of the facilities that purchased a Phillips Healthcare AED between 2005 and 2012 may be in for a shock (or not, as the case may be). Units including the HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs have experienced an internal electrical component failure. Though these devices do have internal systems for performing self tests and alerting the user of errors, many are being detected as faulty.
If you have an AED in your home that may be among one of the aforementioned units, contact Phillips Healthcare immediately for a replacement unit, or seek out an alternative machine. With over 300,000 Americans yearly collapsing from cardiac arrest, a defibrillator malfunction is not risk not worth taking.Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377433.htm