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-00187-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00187-1
  • 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
    A component of the mrx processor board may be susceptible to damage from electrostatic discharge (esd). damage to these components can disrupt ecg and spo2 functionality leading to an inability to perform:- demand mode pacing- 12 lead ecg acquisition and analysis- ecg monitoring via leads- pulse oximetry (spo2)the presence of this condition will be displayed on the ready for use (rfu) indicator as a solid red x with periodic audio chirp.
  • Action
    A hardware upgrade will be provided to correct the issue. Philips is advising healthcare professionals that the MRx can continue to be used prior to receiving the hardware update. Philips is also advising users to immediately contact their Philips authorised service personnel if it is observed that the MRx is displaying a solid red ‘X’ in the RFU indicator and displaying the 'ECG Equip Malfunction' INOP, a failure that may disable some ECG and SpO2 functionality.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Model / Serial
    Philips HeartStart MRx Monitor/DefibrillatorModel numbers M3535A, M3536A, M3536J, M3536MCSerial numbers within the following ranges:Model M3535A: US00100100 to US00541372Model M3536A: US00100902 to US00541375Model M3536J: US00209838 to US00332675Model M3536MC: US00500001 to US00500020 ARTG Number: 95661
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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