Events

Recall of Philips HeartStart MRx Monitor/Defibrillator with Q-CPRAFFECTED PRODUCTSProduct: Q-CPR meter and CPR sensor used with Philips HeartStart MRx Monitor/Defibrillator with Q-CPR option.

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-2015-RN-00832-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-08-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00832-1
  • 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
    Adhesive pads:during internal review, philips identified that the instructions on attaching the q-cpr meter adhesive pad to the q-cpr meter could be improved. patient chest injury:instructions did not inform the users that properly performed cpr can result in injuries to the patient.
  • Action
    Philips has updated the HeartStart MRx’s Instructions for Use associated with Q-CPR meter and CPR sensor via an addendum. The addendum has instructions on application of the disposable adhesive pads, which are used with the Q-CPR meter, including a diagram which illustrates proper placement and orientation of this pad. In addition, the addendum includes general information on the types of injuries, which may occur during CPR. This action has been closed-out on 24/08/2016.

Device

Philips HeartStart MRx Monitor/Defibrillator with Q-CPRAFFECTED PRODUCTSProduct: Q-CPR meter and ...
  • Model / Serial
    Philips HeartStart MRx Monitor/Defibrillator with Q-CPRAFFECTED PRODUCTSProduct: Q-CPR meter and CPR sensor used with Philips HeartStart MRx Monitor/Defibrillator with Q-CPR option.Units Affected: All Q-CPR meter and CPR sensor, models 453564145481, 453564257691, and M4761A are affected.ARTG: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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