Events

Recall of Philips IntelliVue Patient Monitors and Philips Avalon Fetal MonitorsIntelliVue Patient Monitors, software versions J.21.03 & J.21.19

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-01163-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-10-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01163-1
  • 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
    In time-synchronized automatic/sequence mode the noninvasive blood pressure (nbp) automatic measurement series is stopped inadvertently, if the repetition interval is increased manually by the user (e.G. from 5 to 15 minutes) in between two consecutive measurements.- a prompt message “any ongoing nbp measurement and automatic cycle stopped” is displayed and a single tone sounds when the measurement series is stopped.- after the automated measurement series has been stopped, nbp numeric, repetition time, and time to next measurement are no longer displayed, i.E. the nbp numeric field is blank.If the nbp measurement is stopped, and a patient’s blood pressure is not being monitored, a delay in treatment could occur.
  • Action
    A Philips Healthcare representative will contact customers with affected devices to arrange a software upgrade to correct the issues. During the interim period until the SW is upgraded, customers are advised to make sure, if the NBP repetition interval needs to be increased (e.g. from 5 to 15 minutes), to restart the automatic NBP measurement. This action has been closed-out on 12/08/2016.

Device

Philips IntelliVue Patient Monitors and Philips Avalon Fetal MonitorsIntelliVue Patient Monitors,...
  • Model / Serial
    Philips IntelliVue Patient Monitors and Philips Avalon Fetal MonitorsIntelliVue Patient Monitors, software versions J.21.03 & J.21.19Models and Product Numbers: MP5 (M8105A), MP5SC (M8105AS), MP5T (M8105AT), MP5 Upgrade (M8105AU), MP5SC Upgrade (866327)ARTG Number: 94238Avalon Fetal Monitors, software version J.30.58Models and Product Numbers: FM20 (M2702A), FM30 (M2703A), FM50 (M2705A)ARTG Number: 99202
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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