Events

Recall of Philips IntelliVue MX40 Wearable Patient Monitors manufactured prior to the 6th of July 2015

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-00732-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-06-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00732-1
  • 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
    Philips has identified a higher than expected incidence of speaker failures, which results in the loss of audible alarms when the device is in monitor mode. the failure of the speaker results in the audio capabilities of the speaker being degraded and/or no sound at all. operation in telemetry mode is unaffected by speaker failure until disconnected from the information center, either intentionally or unexpectedly.Monitor mode: the mx40 provides local patient monitoring for a period limited by its battery life. the device will annunciate audible & visual alarms using the speaker & display on the mx40 when the alarm conditions are triggered. extended use in this mode raises the risk of the speaker failing.Telemetry mode: all alarming is automatically managed at the information center. mx40 speaker volume is set to zero & the display is off unless the user enables monitor mode. the device will automatically switch to monitor mode if it loses connection to the telemetry network.
  • Action
    A Philips Healthcare representative will contact customers with affected devices to arrange for shipment of a replacement unit. The replacement device is currently manufactured with the improved hardware speaker design and latest software (includes speaker detection capability and INOP messaging) release. An interim workaround is also given in the Customer Letter until such time as the replacement can be made.

Device

Philips IntelliVue MX40 Wearable Patient Monitors manufactured prior to the 6th of July 2015
  • Model / Serial
    Philips IntelliVue MX40 Wearable Patient Monitors manufactured prior to the 6th of July 2015Product Number: 865351 Service Number: 453564262531 and 453564262551Product Number: 865352Service Number: 453564262571 and 453564262591Serial Numbers: lower than US03556362ARTG Number: 99204
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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