Events

Field Safety Notices about LIFEPAK® CR Plus Automatic External Defibrillator

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland 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 Number
    SN2010(08)
  • Date
    2010-07-19
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/lifepak-cr-plus-automatic-external-defibrillator&id=0b8bf825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    The potential for the lifepak® cr plus to not deliver therapy still exists due to a device upgrade that has not been completed on all of the affected devices on the irish market.
  • Action
    1. Ensure the appropriate personnel are made aware of this notice.  2. Identify affected LIFEPAK® CR Plus defibrillators (Please see Attachment 1 for affected serial numbers)  3. Confirm if defibrillators have been upgraded by Oxygen Care (repair and servicing company for Physio-Control products in Ireland) in relation to this issue.  4. If any of the affected defibrillators has not been upgraded, immediately contact Medtronic or Oxygen Care (see contact details below) to arrange the correction of the defibrillator, and follow the recommendations listed in the FSN.  5. Perform regular monthly inspection as per LIFEPAK® CR Plus operating instructions AND verify that the voice prompt is heard at power on.  6. If, at any time, the voice prompt is not heard or any other indicator displays bar “OK”, immediately contact Medtronic.

Device

LIFEPAK® CR Plus Automatic External Defibrillator
  • Model / Serial
  • Product Description
    LIFEPAK® CR Plus Automatic External Defibrillator
  • Manufacturer
    Physio-Control

Manufacturer

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