Events

Recall of LIFEPAK 1000 Defibrillators

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Physio-Control Australia Pty 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
    RC-2017-RN-00114-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-01-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00114-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Physio-control has received reports where lifepak 1000 defibrillator units have shut down unexpectedly during patient treatment. customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to an intermittent connection between the battery and the device electrical 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. physio-control has determined that this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. this condition can occur over time in lifepak 1000 devices that are exposed to vibration, and have a battery installed for long periods of time. this issue can potentially affect any lifepak 1000 device.
  • Action
    Physio-Control is contacting users and advising them to immediately remove and reinstall the battery from their device(s). Users are also being advised to implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices. The removal and reinstallation of the battery will clean the contacts of oxidation and will reduce the likelihood of this issue from occurring. Physio-Control will be initiating a hardware device correction for all affected LIFEPAK 1000 devices and will contact customers to schedule device corrections once the hardware correction is ready for implementation.

Device

LIFEPAK 1000 Defibrillators

Manufacturer

Physio-Control Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA