FDAnews Device Daily Bulletin

MHRA Issues an Alert for Physio-Control’s Defibrillator

May 22, 2017

The Medicines and Healthcare products Regulatory Agency (MHRA) issued an alert for Physio-Control’s defibrillator over the risk of an intermittent connection between the battery and device contacts because of wear and subsequent corrosion.

The manufacturer issued an alert advising that if the device power shuts off unexpectedly, the battery should be removed and reinstalled to restore power to the device.

This issue potentially affects all Lifepak 1000 devices.

There are more than 10,000 of the devices in the UK. — Cynthia Jessup

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