Events

Safety Alert for IntelliVue Information Center and Philips IntelliVue Information Center iX

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

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
    2012-12-07
  • Event Date Posted
    2012-12-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121207.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 information center and philips intellivue information center ix medical device supplier, philips healthcare, has issued a medical device safety alert regarding philips intellivue information center and philips intellivue information center ix. this issue affected all piic and piic ix products using hewlett packard rp5800 pcs. philips has identified that an internal audio cable connector may have diminished retention force due to damaged contacts. this diminished retention force could lead to intermittent or loss of audible alarms. failure to annunciate audio alarms may delay recognition of an alarm condition, if users do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system, e.G., a bedside monitor. this may result in delayed treatment of the patient. the manufacturer advises users to observe system for any of the described symptoms. if experiencing intermittent audio or there is no audio from the piic / piic ix, while it is not connected to another audible alarm annunciation system, users should not rely exclusively on the audible alarm system for patient monitoring. as this issue does not affect video functionality, visual alarming remains operational and close observation of the piic / piic ix display should be provided. philips will replace the audio cable on affected devices. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 december 2012.

Device

IntelliVue Information Center and Philips IntelliVue Information Center iX
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips IntelliVue Information Center and Philips IntelliVue Information Center iX
  • Manufacturer
    Philips Healthcare

Manufacturer

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