Events

Rappel de Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature MonitorIntegra Camino Intracranial Pressure (ICP) Monitor

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Integra Neurosciences Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00030-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-08
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00030-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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.

Device

Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature Mon...
  • Modèle / numéro de série
    Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature MonitorIntegra Camino Intracranial Pressure (ICP) MonitorCatalogue Number: CAM02 All serial numbers affectedIntegra Licox PtO2 and Temperature MonitorCatalogue Number: LCX02All serial numbers affectedARTG Number: 216915 and 217355
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd