AUDIENCE: Risk Manager, Emergency Medicine, Health Professional
ISSUE: FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare. Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation. These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite.
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.
In September 2012, Philips Healthcare initiated the recall of HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs due to the failure of an internal electrical component. The recall affected approximately 700,000 devices. In a Medical Device Safety Notice dated November 19, 2013, Philips provided consumers with updated information about the failure of an internal electrical component that could cause the AEDs to fail to deliver a shock.
In March 2013, the FDA issued a proposed order that if finalized would require manufacturers of AEDs and accessories to submit premarket approval applications that focus specifically on the critical requirements necessary to assure AEDs are safe and effective. The main objective of this proposed regulatory approach is to improve the reliability of AEDs so that they can continue to save lives.
RECOMMENDATION: All owners of the Philips HeartStart AEDs should contact Philips Healthcare immediately at 1-800-263-3342, and select option 5 for technical support. Live technical support is available Monday – Friday, 7:00 am – 5:00 pm Pacific Time. All owners should keep the recalled HeartStart AED in service until Philips Healthcare replaces the device or you can obtain another working AED. If unsure if Philips HeartStart AED is affected by this recall or you received a replacement unit after the September 2012 recall notification, please contact Philips Healthcare for additional information. Please be aware that the Philips HeartStart AEDs are designed to automatically test themselves at regular intervals to ensure they are ready for use. The HeartStart AED should emit a triple chirp sound and have a flashing “i-button” if it detects a serious problem that could prevent the HeartStart AED from delivering an electrical shock. For additional information, please refer to the safety communication.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[12/03/2013- Press Release - FDA]
[12/03/2013 -Safety Communication - FDA]