Events

Field Safety Notices about LIFEPAK 1000

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 received 34 incident reports where customers attempted to use their lifepak 1000 defibrillator and the device unexpectedly switched off during the treatment of the patient. this unexpected shutdown is due to interruptions in the connection between the battery and the device contacts. in this scenario, the defibrillator may not be therapeutic during resuscitation attempts, which can put the patient at risk of serious injury or death. we know examples of 8 negative events in connection with this problem.

Device

LIFEPAK 1000

Manufacturer

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