Events

Recall of LIFEPAK 1000 SYSTEM - DEFIBRILLATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHYSIO-CONTROL CANADA SALES LTD.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29790
  • Event Risk Class
    I
  • Event Initiated Date
    2017-01-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • 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.

Device

LIFEPAK 1000 SYSTEM - DEFIBRILLATOR
  • Model / Serial
    Model Catalog: 99425-XXXXXX (Lot serial: > 1000 numbers contact mfg)
  • Product Description
    LIFEPAK 1000 DEFIBRILLATOR
  • Manufacturer
    PHYSIO-CONTROL CANADA SALES LTD

Manufacturer

PHYSIO-CONTROL CANADA SALES LTD
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC