Events

Safety Alert for intellivue patient monitors and avalon fetal monitors

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-10-15
  • Event Date Posted
    2014-10-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141015.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: philips intellivue patient monitors and avalon fetal monitors medical device manufacturer, philips, has issued a field safety notice (fsn) concerning: intellivue patient monitors with software revisions j.21.03 and j.21.19; and model (product) numbers of mp5 (m8105a), mp5sc (m8105as), mp5t (m8105at), and mp5 upgrades (m8105au, 866327) avalon fetal monitors with software revision j.30.58; and model (product) numbers of fm20 (m2702a), fm30 (m2703a) and fm50 (m2705a) in time-synchronized automatic/sequence mode the non-invasive 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. customers with affected devices will be contacted to arrange a software upgrade to correct the issues. during the interim period until the software is upgraded, users should make sure, if the nbp repetition interval needs to be increased (e.G. from 5 to 15 minutes), to restart the automatic nbp measurement. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 15 october 2014.

Device

intellivue patient monitors and avalon fetal monitors
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips IntelliVue Patient Monitors and Avalon Fetal Monitors
  • Manufacturer
    Philips

Manufacturer

Philips
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH