Events

Recall of Philips HeartStart MRx Monitor/Defibrillator with Q-CPR

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-00196-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00196-1
  • 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 the heartstart mrx is in aed mode, the q-cpr meter is designed to display the ‘do not touch the patient’ icon during the shock advisory analysis period. if the user continues to deliver chest compressions when the shock advisory analysis begins, the ‘do not touch the patient’ icon may incorrectly remain on the screen after analysis or shock delivery is complete.When the heartstart mrx is in manual mode, the q-cpr meter is designed to display the ‘do not touch the patient’ icon when the device is charging to the selected energy. if the clinician continues to provide chest compressions while the device is charging, the q-cpr meter ‘do not touch the patient” icon may incorrectly remain on the screen after shock delivery is complete.Due to incorrect cpr instructions, the clinician may follow the 'do not touch the patient command on the q-cpr meter and may not resume chest compressions in a timely manner resulting in a delay in the delivery of cpr.
  • Action
    A software upgrade will be provided to customers with affected devices. Customers are advised to use their HeartStart MRx without the Q-CPR meter attached. If customers choose to use the HeartStart MRx with the Q-CPR meter attached and they observe that the Q-CPR meter is displaying the 'Do Not Touch The Patient' icon at an unexpected time, follow the MRx Instructions For Use and remove the eter from the patient and continue CPR according to their organization's protocol.

Device

Philips HeartStart MRx Monitor/Defibrillator with Q-CPR
  • Model / Serial
    Philips HeartStart MRx Monitor/Defibrillator with Q-CPRUnits Affected: MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587ARTG Number: 95661
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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