LIFEPAK 20e DEFIBRILLATOR/MONITOR (2017-12-07)

Starting date:

December 7, 2017

Posting date:

January 8, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-65536

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  Reason
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  Affected products

Affected Products

LIFEPAK 20e DEFIBRILLATOR/MONITOR

Reason

Physio-control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death. These failures are the result of manufacturing process residue located beneath a component mounted on the Power Printed Circuit Board Assembly (PCBA). There have been no adverse events reported as a result of this issue.

Affected products