Events

Rappel de CARESCAPE R860 ventilators with software version 10SP05

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia 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-2017-RN-01523-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-12-19
  • 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-2017-RN-01523-1
  • 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
    There is a potential for the display processor to experience an unexpected failure. if this failure occurs, the device screen will temporarily go blank and will then display an error code “ec01 xx”. the blank display results in loss of monitored data being displayed to the user. there have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising users that the system can continue to be used. In the event this issue occurs, an audible alarm will sound. Mechanical ventilation will continue at previous settings. A device restart is required to clear the alarm condition. Consider using appropriate alternative means of ventilation such as a self-inflating bag or another ventilator to prevent patient injury while restarting the device. GE Healthcare will be implementing a software upgrade as a permanent correction.

Device

CARESCAPE R860 ventilators with software version 10SP05

Manufacturer

GE Healthcare Australia Pty Ltd