Events

Safety Alert for IntelliVue patient 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
    2012-02-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120214b.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
    Field safety notice: philips intellivue patient monitors the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning philips intellivue patient monitors. philips has recently received reports that, under certain circumstances, alarms announced at the patient monitor are not announced (either visual or audible) at the central station. only the below referenced models with sw revision h (up to and including h.15.36) are affected. mp20 (m8001a), mp30 (m8002a), mp40 (m8003a), mp50 (m8004a), mp60 (m8005a), mp70 (m8007a), mp80 (m8008a), mp90 (m8010a), intelligent display d80 (m8016a), mx600 (865242), mx700 (865241) and mx800 (865240) if a patient develops a condition leading to an alarm and is being monitored with a monitor which has entered the state where alarm information is not communicated to the central station, clinical personnel monitoring the central station may not be advised of an alarm condition. this could cause a delayed response to the alarm condition of the patient. philips will conduct software upgrade to the affected devices. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

IntelliVue patient monitors
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips IntelliVue patient monitors
  • Manufacturer
    Philips

Manufacturer

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