Events

Rappel de Corpuls3 CO2 Disposable Naso-oral Adaptor Capone

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-2017-RN-00535-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-01
  • 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-2017-RN-00535-1
  • 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
    There have been two local reports of the mouth piece part of the device being dislodged into the throats of patients. the mouth piece is manufactured to be manually removed if clinically necessary. the results of an investigation revealed that it occurred due to a high level of patient agitation. there is a potential risk of asphyxiation if this problem occurs.
  • Action
    Device Technologies is updating the IFU (Instructions for Use) to state that it should only be used on patients who can tolerate the adapter and that the oral breath collector may come loose under extreme conditions and could be aspirated. Users are also requested to retain a copy of their recall letter with the IFU of the affected device.

Device

Corpuls3 CO2 Disposable Naso-oral Adaptor Capone
  • Modèle / numéro de série
    Corpuls3 CO2 Disposable Naso-oral Adaptor CaponeProduct Code: CP-4234.21All Lot NumbersARTG Number: 281369 and 192745
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd