Events

Rappel de PDM module with Frame F5-01 used with CARESCAPE Monitor B850

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-2013-RN-01136-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-06
  • 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-2013-RN-01136-1
  • 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 pdm patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the f5-01 frame due to an issue with the pdm ethernet communication hardware. the communication loss may occur when the pdm is first attached to the host monitor, or it may lose communication spontaneously during use with no user action. communication is not automatically re-established. loss of communication with the host monitor results in a loss of monitoring for the parameters provided by the pdm module, however an audible and visual alarm will be displayed.
  • Action
    GE Healthcare are providing work around instructions for users to follow. GE will be replacing the affected frames as a permanent correction. This action has been closed-out on 10/02/2016.

Device

PDM module with Frame F5-01 used with CARESCAPE Monitor B850
  • Modèle / numéro de série
    PDM module with Frame F5-01 used with CARESCAPE Monitor B850 ARTG Number: 115304
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd