Lifepak 500 Automatic External Defibrillator (2020-05-05)

Starting date:

May 5, 2020

Posting date:

May 22, 2020

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-73159

Last updated: 2020-05-22

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  Reason
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  Affected products

Affected Products

Lifepak 500 Automatic External Defibrillator

Reason

Stryker has become aware via a single customer complaint [June 2018] that LIFEPAK 500 AEDs in high-use environments (Emergency Medical Services) may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. Wear-through of the connector exposes base metal on which an oxide layer may form and result in the device not recognizing a patient is connected. When this circumstance arises, the device will provide the user the "CONNECT ELECTRODES" message.

Affected products