Events

Alerte De Sécurité sur Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature Monitor

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Integra Lifesciences.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-01-12
  • Date de publication de l'événement
    2016-01-12
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160112.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature Monitor
  • Manufacturer
    Integra Lifesciences

Manufacturer

Integra Lifesciences