Events

Rappel de CARESCAPE respiratory modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE & the Airway Gas Option N-CAiO

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-00776-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-07-14
  • 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-00776-1
  • 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
    Displayed et-/fi o2 values may be incorrect. a random deviation from the allowed tolerance limits of an o2 sensor component in the carescape respiratory modules, the airway gas option and their respective service exchange units could cause up to 50% measurement error in et-/fi o2 values. an incorrect et- /fi o2 value could lead to a potential hypoxic situation or impaired clinical decision making.
  • Action
    End users are advised to identify if they have any affected Airway Gas Option modules in their care. If any affected units are identified end users are requested to stop using the module and to contact technical support to arrange for correction. This action has been closed-ouit on 20/07/2016.

Device

CARESCAPE respiratory modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE & the Airway ...

Manufacturer

GE Healthcare Australia Pty Ltd