Wednesday, October 27, 2021

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.