The FDA has issued a Safety Communication headlined: “HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication – Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock.”
There is a recall of 700,000 Philips Healthcare Automated External Defibrillators (AEDs) because there is a possibility of failure in life or death situations. Philips says that the AEDs may not be able to deliver life-saving shocks to people in emergency situations due to an electronic malfunction.
The FDA provides this background: “An AED is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly.”
The recalled models were sold between 2005 and 2012. and sold under the brand names HeartStartFRx, HeartStartHome and HeartStartOnsite. According to the FDA, “The Philips HeartStart FRx AED may be used by first responders including Emergency Medical Services (EMS) and fire departments. The Philips HeartStart HS1 Home AED may be used in the home. The Philips HeartStart HS1 OnSite AED may be used in public locations including airports, community centers, schools and government buildings.”
To date, 61 devices have been repaired or replaced due to the problem, however there have been no reports of any patient being harmed as a result of this recall. Even though there is a recall, the FDA feels the benefits of attempting to use the AED in a cardiac arrest emergency to outweigh the risk of not attempting to use the AED.
For the complete FDA Recall Alert, click here.
FDA 12/3/13 News Release
Some defibrillators may not deliver shock, FDA warns