Events

Safety Alert Or Field Safety Notices for Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS

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
    2016-10-13
  • Event Date Posted
    2016-10-13
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/automatic-external-defibrillator-aed-lifepak-cr-plus-and-lifepak-express-risk-of-failure-to-deliver-a-shock
  • 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
    LIFEPAK CR Plus AEDs or LIFEPAK EXPRESS AEDs may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened. The problem is due to an internal component (reed switch) that can intermittently become fixed in the closed position. A defibrillator in this condition will fail to deliver a shock.
  • Reason
    Manufactured by physio-control – risk of delay to defibrillation due to an intermittent component failure. specific serial numbers are affected.
  • Action
    Ensure that all those responsible for the AED follow the instructions in the manufacturer’s Field Safety Notice FSN To check if your AED is affected call Physio-Control customer support or visit their website and go to ‘Search Affected Devices’ and enter the serial numbers. If the AED is faulty, remove the unit from service and contact Physio-Control to arrange for it to be corrected. If you have already acted on this FSN, no further action is required.

Device

Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS
  • Model / Serial
  • Product Description
    The AED can be found in hospitals and in public places (eg railway stations, village halls and supermarkets).
  • Manufacturer
    Physio-Control

Manufacturer

Physio-Control
  • Manufacturer Address
    Physio-Control Operations, Netherlands Telephone: 0808 258 0094Email: RS.EMEArecall@physio-control.com
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    MHRA