Heartstart Fr2+ Automated Exteranal Defibrillators Recalled Due to Memory Chip Failure that Causes Device to Fail

The manufacturer of the Heartstart Fr2+ Automated External Defibrillators (AEDs), Phillips Healthcare, has recalled this product due to possible failure of the device as a result of memory chip failure thats makes the device unrealiable and possibly inoperable in emergency situations. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured from May, 2007 to January, 2008 are the devices involved in this recall. The HeartStart FR2+ defibrillator is used by trained responders and designated response teams to treat sudden cardiac arrest. The device is designed to automatically analyzes the patient's heart rhythm and advises the responder whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy. The manufacturer of this device has has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. These reported failures were detected during routine self tests, not during emergency use of the AED. The failure of this chip can render the AED inoperable and prevent it from delivering therapy when indicated, although Philips has received no reports of injury associated with this chip failure. Customers are directed to call or report product concerns or problems regarding this product to HeartStart Customer Service at 800.263.3342 and any adverse events experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 800. 332.1088, by fax at 800.322.0178, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch. _________________________________________

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