Events

Rappel de CARESCAPE Central Station (CSCS) software version 2.0.2 All-in-one

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-2018-RN-00046-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-01-12
  • 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-2018-RN-00046-1
  • 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
    Ge healthcare has become aware of an issue with the carescape central station (cscs) software version 2.0.2 units. after boot-up or system start up, cscs v2.0.2 units may display unexpected no comm notifications in the patient multi-viewer or single viewer window when the cscs is connected to both the mission critical (mc) and the information exchange (ix) networks. if a no comm notification is displayed, all patient waveforms, parameter data and alarms are lost at the cscs and patients admitted to telemetry transmitters are unmonitored unless monitored via other central stations, bedside monitors or direct clinical observation. there have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising customers who are experiencing the NO COMM safety issue to follow instructions outlined on the customer letter to restore communication between the CSCS and patient monitoring devices in the interim. GE will arrange for a software correction to resolve this issue.

Device

CARESCAPE Central Station (CSCS) software version 2.0.2 All-in-one
  • Modèle / numéro de série
    CARESCAPE Central Station (CSCS) software version 2.0.2 All-in-one GTIN 00840682109666; Desktop GTIN 00840682109604ARTG Number: 132673 (GE Medical Systems Australia Pty Ltd - Patient monitor, central unit)
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd