Events

Recall of Physio-Control Lifepak 1000 Defibrillators

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Physio-Control Corporation.

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
    21045
  • Event Initiated Date
    2017-02-03
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Medxus Ltd, Unit 4, 100 Fitgerald Avenue, Christchurch 8011
  • Reason
    Reports of incidents where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly during patient treatment. this unexpected shut down is due to an intermittent connection between the battery and device contacts, the company 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, however customers with non-rechargeable batteries who do not routinely remove the battery for inspection, as indicated in the lifepak 1000 defibrillator operating instructions, are more susceptible to this issue.
  • Action
    Manufacturer to issue advice regarding use

Device

Physio-Control Lifepak 1000 Defibrillators

Manufacturer

Physio-Control Corporation
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA