Events

Recall of Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 (manual 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-2012-RN-00738-3
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-07-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00738-3
  • 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
    Some heartstart mrx monitor/defibrillators may contain compromised electronic components and present the following behaviours:·in automatic external defibrillator (aed) mode, the mrx may have difficulty interpreting the pads ecg waveform. the mrx may incorrectly analyse the rhythm or may fail to analyse the rhythm.· in manual defibrillation mode, if the pads/paddles ecg signal is viewed, the user may have trouble interpreting the pads/paddles waveform and determining whether or not to deliver therapy.· when using q-cpr measurement and feedback, the feedback on ventilation rate may be inaccurate.
  • Action
    Philips is replacing the affected component at customer facilities and is providing preventative/work around instructions.

Device

Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, M3536M4, M...
  • Model / Serial
    Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 (manual defibrillator)Multiple affected units ARTG Number: 95661
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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