Events

Safety Alert for expression information portal - ip5

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
    2013-10-16
  • Event Date Posted
    2013-10-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016a.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 expression information portal - ip5 the therapeutic goods administration (tga), australia issued a medical device safety alert concerning expression information portal - ip5, manufactured by philips. the affected product number is 865471 and the affected serial numbers are us23200375, us23200376, us23200377. if the affected product is in use or powered on for an extended period of time (exceeding 24 hours), it may lost all audio function. "all audio" includes touch screen and qrs/spo2 modulation tones and audible alarms. all other functionality of the affected product is unaffected (waveforms, numeric values, visual alarm indications). the manufacturer will contact the affected customer to arrange for a software update to correct the problem. end users are requested to power cycle the affected product once every 24 hours and to be aware not to rely solely on audible alarms for alerting of potentially critical patient events. .According to the local supplier, the affected products were not distributed in hong kong. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01052-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 october 2013.

Device

expression information portal - ip5
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Expression Information Portal - IP5
  • Manufacturer
    Philips

Manufacturer

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