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-01275-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-12-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01275-1
  • 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
    Issue 1: the mrx can be susceptible to interference from electrical fast transients (efts) when connected to ac or dc power, operating with a lan cable, or operating near a source of eft interference, which could cause therapy to be delayed or delivered inadvertently.Issue 2: if a user undertakes certain atypical clinical workflows (ie, when using external paddles for defibrillation or when using the periodic clinical data transmission (pcdt) option on the mrx), the mrx can exhibit unexpected behaviour. these workflows do not correspond to instructions in the mrx instructions for use (ifu) and are not expected to be performed by trained clinicians. in addition, these device behaviours have only been observed during internal testing, and have not been reported during clinical use. issue 3: the mrx could stop demand mode pacing due to an ecg leads-off condition when electrode-to-skin contact impedance values are outside design ranges for detection.
  • Action
    A software upgrade will be implemented for all units affected by one or more of the above issues. Users are advised that they can continue to use their MRx prior to receiving the software upgrade, provided they follow the temporary workaround instructions provided in the customer letter.

Device

Philips HeartStart MRx Monitor/Defibrillator

Manufacturer

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