Events

Rappel de Avance CS2, Avance, and Amingo anaesthesia devices with the optional large tray insert accessory installed

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-2016-RN-01406-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-27
  • 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-2016-RN-01406-1
  • 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 a potential safety issue where certain avance cs2, avance and amingo anaesthesia devices can transition to a system malfunction state if the lower storage drawer containing the optional large tray insert accessory, is closed with an abnormally high amount of force. should the anaesthesia device transition to a system malfunction state the device will perform in the following manner:- automatically activate alternate oxygen flow within a few seconds,- provide high priority audible and visible alarms,- provide on display instructions to set the oxygen (o2) flow and manually ventilate the patient,- continue to deliver anaesthetic agent at the existing vaporizer setting.If the system malfunction is left unresolved, it could result in loss of patient ventilation potentially resulting in hypoxia. there have been no injuries reported as a result of this issue.
  • Action
    GE is advising users that they can continue to use their Avance CS2, Avance, and Amingo devices after the optional large tray insert accessory has been removed. Customers are requested to destroy all large tray inserts in their possession.However, customers should contact GE if they choose to return the tray insert. This action has been closed-out on 18/05/2017.

Device

Avance CS2, Avance, and Amingo anaesthesia devices with the optional large tray insert accessory ...
  • Modèle / numéro de série
    Avance CS2, Avance, and Amingo anaesthesia devices with the optional large tray insert accessory installed Part Number of large tray insert : 1009-3260-000ARTG Number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd