Events

Recall of Philips IntelliVue MX40 Patient Wearable Monitor s/w versions B.05.28, B.05.29 and B.05.32

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-2016-RN-01297-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01297-1
  • 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 local "alarms on" configuration setting on the phillips intellivue mx40 patient wearable monitor is modified from its factory default, in certain software revisions, it will disable generation and delivery of ecg alarms to the philips intellivue information center ix (piic ix) without a visual indication on the piic ix that the ecg alarms have been disabled. if the generation and delivery of ecg alarms to the information center is disabled without a corresponding visual indication at the information center, a delay in treatment could occur.
  • Action
    Phillips is implementing software upgrade for affected Phillips IntelliVue MX40 Patient Wearable Monitors. Users with affected devices will be contacted by a Phillips Healthcare representative for the installation of the software upgrade. In the interim, users are advised to make sure that the MX40 Patient Wearable Monitor local configuration setting ‘Alarms On’ is configured to its factory default. Philips is providing instructions to change the local configuration settings in the customer letter.

Device

Philips IntelliVue MX40 Patient Wearable Monitor s/w versions B.05.28, B.05.29 and B.05.32
  • Model / Serial
    Philips IntelliVue MX40 Patient Wearable Monitor s/w versions B.05.28, B.05.29 and B.05.32Product Numbers: 865351, 865352 Exchange Part Numbers: 453564262531, 453564262551, 453564262571, 453564262591, 453564615351, 453564615371Product number and Exchange part number (identified as Service #) are displayed on the devices product label located on the back of the deviceARTG Number: 99204
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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