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-2017-RN-00401-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-03-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00401-1
  • 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
    The possibility of abnormal device behaviours has been identified in the heartstart mrx monitor/defibrillator. the device may exhibit the following issues:1. if the battery connecting pins (in the battery compartment of the heartstart mrx monitor/defibrillator) become damaged or contaminated, it could result in a poor electrical connection that may cause the mrx to either (i) not power on or (ii) repetitively reboot, when used on battery power only 2. after unplugging the device from ac mains, there are two abnormal behaviours of the heartstart mrx monitor/defibrillator that may occur:a) after the user depresses the charge button, the device attempts to charge, and after approximately 20 seconds, generates the “shock equipment malfunction” error message and is unable to deliver shock therapy.B) pacing may cease without warning. these device behaviours continue until the unit is reset.Either problem could potentially delay monitoring or therapy.
  • Action
    Philips is advising customers to take the following corrective actions: Issue 1, inspect the HeartStart MRx battery compartment connections on the device. Include this step as part of a routine Operational Check to verify that the battery connector pins are clean, fully extended, not bent, and without residue; and Issue 2, if the External Power Indicator light above the MRx display remains illuminated after the device is unplugged from AC mains power, leave the device unplugged, remove and reinsert the battery and confirm that the Indicator has turned off. Customers are requested to refer to their recall notification letter for further important details.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Model / Serial
    Philips HeartStart MRx Monitor/DefibrillatorModel Numbers: M3535A, M3536A, and military bundles Units: M3535A (M3535ATZ)M3536A (M3536ATZ)M3536M, M3536MCM3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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