Events

Recall of IntelliVue MX40 Software Versions: B.00.x and B.01.x

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-00676-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-06-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00676-1
  • 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 alarm pause time is user selectable from 1 to 3 minutes, with a default of 2 minutes, when operating the mx40 with the piic ix.When the following specific conditions are met, the alarm pause time does not automatically restart when it reaches its selected time limit:- the pause alarms configuration is enabled in the non-default setting of both red and yellow level alarms;- the mx40 is selected for the non-default setting of monitor mode;- the pause alarms is initiated to pause an active alarm or to maintain a short ‘non-alarm’ state while in the patient’s vicinity; and- an alarm condition occurs during the pause alarms time.The mx40 will continue to display “alarms paused: 0:00” and the piic ix will display “alarms paused” until the pause alarms feature is disabled manually.
  • Action
    Philips is advising their customers that the following two items must be configured when using the MX40 with the IntelliVue Information Center iX: 1. Utilise the default state of Pause Alarms at Yellow only, which disables the ability to Pause/Suspend all Red level alarms. 2. Utilise the default state of Remote Suspend Alarms as off, which disables the use of the Pause Alarm feature of the MX40 device. Philips will implement a software update to correct the issue. This action has been closed-out on 12/02/2016.

Device

IntelliVue MX40 Software Versions: B.00.x and B.01.x
  • Model / Serial
    IntelliVue MX40 Software Versions: B.00.x and B.01.xPart Numbers: 865350 and 865352ARTG Number: 99204
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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