FDA Warns Certain HeartStart AED Devices Cannot Deliver Proper Shock

The FDA published the warning in a safety communication on Dec. 3

According to a press release from the FDA, certain HeartStart automated external defibrillators (AEDs) may not be able to deliver the necessary shock in a cardiac emergency. The FDA released this information to the public on Dec. 3, 2013 as part of a safety communication for people who have used the previously recalled devices.

The safety communication released, according to the FDA, urges users to better inspect and monitor the readiness of the devices, made by Philips Healthcare. The FDA also suggests that people learn the steps to follow in the event that a cardiac emergency warrants the use of a recalled device.

According to the article, one shouldn’t simply discard the recalled device immediately. The FDA recommends that people keep the devices on hand until a new version is released, as it is more beneficial to use a recalled device that no device at all during a cardiac arrest scenario. The devices in question were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home and HeartStart HS1 OnSite.

Philips Healthcare initially began recalling the devices in September 2012, and in mid-November 2013, warned users about the failure of an internal electrical component that could cause the AEDs to fail.

For more information, visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377433.htm

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