Events

Rappel de Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient 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 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-2012-RN-00805-3
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-08-08
  • 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-2012-RN-00805-3
  • 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 dash monitor may exhibit an unexpected loss of custom automatic nbp measurement cycling. custom automatic nbp measurement is a feature introduced in dash version 6.0 which allows the user to program up to 4 different nbp auto mode sequences. when a view of another patient with an nbp parameter on the network occurs, if the custom automatic nbp measurement cycling function is enabled, the function will turn off unexpectedly. the issue can occur when manually viewing another bed on the network using the view other beds option or automatically with the automatic view on alarm (avoa) feature.
  • Action
    GE Healthcare is providing users with work around instructions to mitigate the issue. A software update will be implemented to permanently fix the issue when available.

Device

Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient m...
  • Modèle / numéro de série
    Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient monitor).Monitors with software versions 6.0 and later may be affectedARTG Number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd