Events

Field Safety Notices about LIFEPAK CR® Plus AED and LIFEPAK EXPRESS®

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia 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
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Physio-control has encountered a problem where aifs lifepak cr plus or lifepak express do not start sounding when the on / off button is pressed when the cover is opened due to an internal component (pole switches), however, it may occasionally remain fixed in the closed position. physio-control has found that there are currently 25,178 devices in circulation, of which about 9,600 have this defective component. such a defibrillator will not trigger shock, so potential treatment will not be performed and the patient will not be resuscitated. all reports we received from customers were provided at initial preparation and when testing the device. to date, we have not received reports of patient-related events.

Device

LIFEPAK CR® Plus AED and LIFEPAK EXPRESS®

Manufacturer

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