Events

Rappel de CARESCAPE Monitor B850 (with software versions 1.0.12 and earlier) and CARESCAPE Monitor B650 (with software version 1.1.12 and earlier)

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-01109-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-10-31
  • 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-01109-1
  • 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
    Non-invasive blood pressure (nibp) - auto-cycling not starting/stopping, nibp measurement not performed if network time update occurs at same time, infants limits are incorrect. ecg- wrong ecg bandwidth in e-psm(p) or e-(p)re(s)tn module. changing primary ecg lead selection will not change primary measurement in pdm or tram.Central monitor- a temporarily hidden alarm message will not reactivate if different alarm is acknowledged, audible alarm missing after broken network connection, ecg not shown on icentral, standby doesn't end, & incorrect labelling on v leads.Ventilation alarms- incorrect display of airway pressure in bed to bed view, spirometry alarm limits can't be changed.General- alarm off issues in small parameter window, auto-discharge doesn't erase data, invasive pressure lables incorrect.Tram -missing service alarm bed to bed view doesn't show highest st value in s/5 network, missing remote alarm & avoa alarm, monitor disconnect alarms not restored.
  • Action
    GE Healthcare is advising users of work around instructions to follow as an interim measure. GE is providing users with a laminated sheet summarising the work around instructions to keep near the affected units for easy reference until the software update is implemented to correct the issues. This action has been closed-out on 12/02/2016.

Device

CARESCAPE Monitor B850 (with software versions 1.0.12 and earlier) and CARESCAPE Monitor B650 (wi...
  • Modèle / numéro de série
    CARESCAPE Monitor B850 (with software versions 1.0.12 and earlier) and CARESCAPE Monitor B650 (with software version 1.1.12 and earlier)ARTG Number: 115304
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd