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Health product recall

LifePak 1000 Defibrillator

Starting date:
January 13, 2017
Posting date:
January 24, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-61924

Reason

Physio-Control has received complaints that the LifePak 1000 Defibrillator is unexpectedly powering off during device usage. This unexpected shut down is due to an intermittent connection between the battery and device contacts. A defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death. This intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. This has been observed to occur in devices that are exposed to vibration and have a battery installed for extended time without being removed from the LifePak 1000 for inspection and then reinstalled.

Affected products

LifePak 1000 Defibrillator

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

99425-XXXXXX

Companies

Manufacturer
Physio-Control, Inc.
11811 Willows Road North East
Redmond
98052
Washington
UNITED STATES