Events

Recall of HeartStart MRx Monitor / Defibrillator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-2013-RN-00622-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-06-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00622-1
  • 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
    The mrx could deliver a non-synchronised shock in the cardioversion mode if the user rotates the therapy knob while simultaneously pressing the 'sync' button, then charges the mrx and presses the shock button. delivery of a non-synchronised cardioversion shock could result in the delivery of incorrect therapy, which may induce ventricular fibrillation.Additionally, the label affixed to the top of the mrx device is not consistent with the instructions for use with regard to the specific steps for the set up of delivery of a synchronised shock.
  • Action
    Philips Healthcare are providing users with work around instruction as an interim measure. A software upgrade and device label revision will be supplied to users as a permanent fix. This action has been closed-out on 11/02/2016.

Device

HeartStart MRx Monitor / Defibrillator
  • Model / Serial
    HeartStart MRx Monitor / DefibrillatorModel numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6Serial Numbers: All serial numbers between US00100100 to US00567299Manufactured between February 2004 and May 2013ARTG Number: 95661
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA