Events

Recall of LifePak CR Plus and LifePak Express Automatic External Defibrillators

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Physio-Control Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01044-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-08-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01044-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Physio-control has become aware of an issue whereby the lifepak plus aed or lifepak express aed may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. the device will turn on and complete the initialisation steps, however , there are no voice prompts provided to the user and the device will enter standby mode. after 15 seconds in standby, the device will switch off. a defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. all reports received from customers have been noted during initial set up and testing of the device. to date, there have been no patient related events.
  • Action
    Physio-Control is providing users with instructions to follow to identify the affected units: · Open the lid and listen for voice prompts within 5 seconds - If the voice prompts are properly activated, press and hold the ON/OFF button for 2 seconds to turn the device off. Continue to monitor your device(s) per your established routine check process until contacted by Physio-Control to arrange component replacement for all affected serial numbers. - If voice prompts are not activated, please remove the device from service and contact Physio-Control at 1 800 890 892 to arrange for device correction. Users are advised to continue to monitor the device(s) per established routine check process until contacted by Physio-Control to arrange component replacement for all affected serial numbers.

Device

LifePak CR Plus and LifePak Express Automatic External Defibrillators

Manufacturer

Physio-Control Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA