Events

Rappel de Hamilton Medical C3 Ventilator

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia.

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-01134-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-29
  • 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-01134-1
  • 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
    The manufacturer has identified an issue related to spo2 monitoring with the use of the hamilton-c3 ventilator. when measuring spo2, the software of the hamilton-c3 can run into a system or cpu overload causing a screen freeze. the alarm buzzer sounds and the device needs to be reset. in case of such a system or cpu overload, the hamilton-c3 stops the ventilation and sounds the alarm buzzer. however, since the screen freezes, no alarm message is displayed to the operator. there have been no injuries reported as a result of this issue.
  • Action
    All the Hamilton-C3 ventilators have SpO2 option deactivated by default as there are no SpO2 sensors in use in Australia. The new software version 2.0.2 will be installed as a permanent correction. This action has been closed-out on 15/02/2017.

Device

Hamilton Medical C3 Ventilator

Manufacturer

The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia