Events

Rappel de Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as part of the original order)

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-2015-RN-00098-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-02-06
  • 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-2015-RN-00098-1
  • 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
    It has been identified that specific combinations of engstrom ventilator casters and bases pose an increased likelihood of failures of the caster mounting hardware. a failure of the caster mounting hardware may result in the ventilator falling/tipping (overbalancing). a fall/tip of the engstrom ventilator can result in serious injury to patients or clinical staff.
  • Action
    GE is replacing all affected accessory carts. End users are advised that they can continue to use the cart until replaced, however the casters must be checked for signs of damage and loosening. This action has been closed-out on 03/08/2016.

Device

Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as p...
  • Modèle / numéro de série
    Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as part of the original order)Serial Numbers: CBCN01062 through CBCQ01396ARTG Number: 108308
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd