January 18, 2017

FDA issues Safety Alert on Lifepak 1000 defibrillators

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on January 14 issued a Safety Alert announcing the voluntary field action by Physio-Control (Redmond, Washington) notifying its customers to immediately remove and reinstall batteries in the Lifepak 1000 defibrillator.

The company has received 34 reports of customers attempting to use the defibrillator, and the device shut down unexpectedly because of an intermittent connection between the battery and device electrical contacts. The intermittent connection is a result of wear and subsequent oxidation formation between the battery and electrical contacts, according to the company.

Physio-Control is aware of 8 adverse events related to this issue.

FDA3

Posted 01/14/2017] AUDIENCE: Emergency Medicine, Risk Manager ISSUE: Physio-Control announced that the company is launching a voluntary field action for the LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment.

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