Events

Recall of LIFEPAK 1000 SYSTEM - DEFIBRILLATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by WORKPLACE MEDICAL FIRST AID TRAINING.

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
    25380
  • Event Risk Class
    II
  • Event Initiated Date
    2015-02-12
  • 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 become aware of incidents where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. a defibrillator in this scenario has the potential to fail to deliver a shock with the potential result that therapy is not delivered and a patient is not resuscitated. we have learned this to be as a result of batteries not being replaced when they have reached a low or very low state of charge as indicated in the readiness display on the device.

Device

LIFEPAK 1000 SYSTEM - DEFIBRILLATOR
  • Model / Serial
    Model Catalog: 99425-XXXXXX (Lot serial: all lots. contact mfg.)
  • Product Description
    LIFEPAK 1000 SYSTEM - DEFIBRILLATOR
  • Manufacturer
    WORKPLACE MEDICAL FIRST AID TRAINING

Manufacturer

WORKPLACE MEDICAL FIRST AID TRAINING
  • Manufacturer Address
    HAMILTON
  • Source
    HC