Events

Safety Alert for Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature Monitor

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

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
    2016-01-12
  • Event Date Posted
    2016-01-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160112.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: integra camino intracranial pressure (icp) monitor and the integra licox pto2 and temperature monitor the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning integra camino intracranial pressure (icp) monitor (catalogue number: cam02; serial number: all) and the integra licox pto2 and temperature monitor (catalogue number lcx02; serial number: all ) manufactured by integra lifesciences (ireland) ltd. according to the alert, the speakers in camino icp monitors (cam02) and the licox pto2 and temperature monitors (lcx02) may potentially malfunction. if this occurs, the monitors will stop providing an audible tone at start-up or at alarm points during use. although unlikely, this may lead to central herniation that could potentially result in brain death or reversible ischemia; moderate hypoxic brain injury; elevation of icp or decrease in pto2. no reports of patient injury or adverse events have been received. the affected units are to be returned to the manufacturer for a software upgrade to lower the input signal supplied to the speaker assembly. the monitor case will also be modified to increase the decibel level. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00030-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 january 2016.

Device

Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature Mon...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature Monitor
  • Manufacturer
    Integra Lifesciences

Manufacturer

Integra Lifesciences