Events

Safety Alert Or Field Safety Notices for LIFEPAK® 1000 defibrillator

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
  • Event Number
    MDA/2014/040
  • Date
    2014-10-09
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-lifepak-1000-defibrillator-manufactured-by-physio-control-mda-2014-040
  • 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
    Risk of failure to deliver a shock.This is due to unexpected shut down of the defibrillator caused by a battery with very low charge.Confusing instructions for use mean that batteries aren’t always replaced when they have a low or very low charge.See the Field Safety Notice (279Kb) for further details.
  • Reason
    (physio-control) due to unexpected shut down of the defibrillator caused by a battery with very low charge. (mda/2014/040).
  • Action
    Identify all LIFEPAK 1000 defibrillators in your possession. Ensure users read the important information in the Field Safety Notice and follow the instructions on how to check if a new battery is required. Make sure that a spare, fully charged battery is always available.

Device

LIFEPAK® 1000 defibrillator
  • Model / Serial
  • Product Description
    LIFEPAK® 1000 defibrillator. Manufactured by Physio-Control. All serial numbers.
  • Manufacturer
    Physio-Control

Manufacturer

Physio-Control
  • Manufacturer Address
    Olivier Anki Physio-Control Operations Netherlands B.V. Galjoenweg 68, 6222 NV Maastricht The Netherlands Tel:    +33 695 475 522Email:    olivier.anki@physio-control.com
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    MHRA