Events

Recall of LIFEPAK 15 Monitor/Defibrillator

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-2017-RN-00102-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00102-1
  • 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 a potential device issue where the lifepak 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (relay) installed on the therapy printed circuit board assembly (pcba). a malfunction of the relay can be identified during the user test of the device. if the user test fails, the device will illuminate the service indicator icon on the device. if the user test passes, the device is safe to use.
  • Action
    Physio-Control is contacting customers with LIFEPAK 15 devices that contain the potentially affected Relay component to arrange for a device correction. This correction will include the replacement of the Therapy PCBA. If needed, loaner devices will be made available while the repairs are being made. In the interim, users are advised to continue to perform the User Test as outlined in the Daily Operator’s Checklist within the LIFEPAK 15 Operating Instructions. If the device fails the User Test, contact Physio-Control immediately to arrange for correction of the device. This action has been closed-out on 25/05/2017.

Device

LIFEPAK 15 Monitor/Defibrillator

Manufacturer

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