Events

Recall of Philips 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-2014-RN-00188-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00188-1
  • 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
    When used in hospital transport and pre-hospital (ems) environments, the connection between the pads/paddles therapy cable (including pads cpr therapy cable, external paddles cable, and internal paddles cable/adapter) and the mrx therapy connection port could experience high levels of stress causing accelerated wear. wear of the connection could prevent the device from sensing that the pads/paddles therapy cable is connected. this wear also could cause the mrx to inappropriately identify the pads therapy cable, external paddles, or internal paddles. pads/paddles therapy cable and therapy connection port wear could pose a risk for patients and/or caregivers.
  • Action
    Philips will be inspecting affected units and implementing hardware corrections if required. Philips is advising healthcare professionals that the MRx can continue to be used prior to receiving the hardware update. However, customers are advised to ensure that ongoing therapy connection inspections are undertaken on MRx devices to detect wear. Customers are advised to remove affected devices immediately from use and contact Philips to arrange service.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Model / Serial
    Philips HeartStart MRx Monitor/DefibrillatorModel Numbers: M3535A, M3536A, M3536J, M3536, & M3536MCSerial Numbers:M3535A: US00100104 - US00572207M3536A: US00100902 - US00543688M3536J: US00209838 - US0332675M3536M: US00500002 - US00500009M3536MC: US00500002 - US00500028ARTG Number: 95661
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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