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FDA Issues Warning on Automated External Defibrillators — Physician’s First Watch

Medical News |
December 5, 2013

FDA Issues Warning on Automated External Defibrillators

By the NEJM Journal Watch Editors

Certain HeartStart automated external defibrillators from Philips Healthcare may not work in cardiac emergencies because an internal electrical component may fail, the FDA has warned.

The devices in question include HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite, all manufactured and distributed between 2005 and 2012. The FDA advises all HeartStart owners to call Philips Healthcare immediately (800-263-3342) for technical support, and to keep their devices until they can be replaced.

The HeartStart defibrillators have prompted 1100 complaints and 580 adverse event reports to the FDA, according to the Wall Street Journal.

Reader Comments (1)

Catherine Rogers RN, MSN, BC Other Healthcare Professional, Psychiatry, Wyoming State Hospital

I appreciate the knowledge and would be interested in being kept informed in other aspects of healthcare. Thank-You.

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