Events

Rappel de Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5 or 5.6 (multi-function 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-2014-RN-00114-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-02-05
  • 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-2014-RN-00114-1
  • 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 solar 8000m/i automatic view on alarm (avoa) feature will stop functioning if the patient monitor is discharged from the cic central station while a remote automatic bedside alarm view is currently being displayed on the solar. once this issue occurs, subsequent remote avoa alarms will not automatically appear on the left side of the solar display. in addition, the user interface menus on the discharged patient monitor will not function correctly. this may result in delayed treatment due to missed alarms that may be serious. this issue can be fixed by rebooting the solar 8000m/i.Parameter, waveforms and alarms associated with the patient directly connected to the solar 8000m/i patient monitor are not affected.
  • Action
    GE Healthcare is advising users that if patients are discharged from the CIC central station to discontinue use of the AVOA feature and is providing instructions to disable the feature. If patients are not discharged from the CIC central station the AVOA feature can continue to be used. This action has been closed-out on 29/01/2016. GE Healthcare will be implementing a software upgrade for all Solar 8000i / M monitors.

Device

Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5 or 5.6 (multi-function pati...
  • Modèle / numéro de série
    Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5 or 5.6 (multi-function patient monitor)ARTG Number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd