Events

Safety Alert Or Field Safety Notices for All LIFEPAK 1000 automatic external defibrillators (AEDs)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Physio-Control.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2017-05-18
  • Event Date Posted
    2017-05-18
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/all-lifepak-1000-automatic-external-defibrillators-aeds-risk-of-device-shutting-down-unexpectedly-during-patient-treatment-and-possible-failure-to-deliver-therapy
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Manufactured by physio-control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
  • Action
    Identify all LIFEPAK 1000 defibrillators in your possession. Ensure that all those responsible for the AED follow the instructions in the manufacturer’s Field Safety Notice (FSN). If you have already acted on this FSN, no further action is required.

Device

All LIFEPAK 1000 automatic external defibrillators (AEDs)
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    The LIFEPAK 1000 defibrillator can be found in hospitals and in public places. The manufacturer’s logo on the front cover may vary, displaying ‘Medtronic’ or ‘Physio-Control’.
  • Manufacturer
    Physio-Control

Manufacturer

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