Events

Rappel de Drager Ventstar Paediatric Circuit, used in conjunction with the Dräger Oxylog 3000plus Transport 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 Draeger Medical 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-00721-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-05-27
  • 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-00721-1
  • 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
    During the course of routine internal testing drager detected isolated leakages at the check valve (one way valve of the inspiration branch) of the above mentioned disposable paediatric ventilation circuit. leakage at the check valve can result in a patient's exhaled gas entering into the breathing circuit, which could lead to the rebreathing of the exhaled gas with subsequent reduced oxygen concentration for the patient. this leakage is not detected during the ventilator operational readiness check. to date, drager has not received any complaints associated with this issue.Further detailed investigations have shown that the check valve functions properly with no leak observed at positive end-expiratory pressures above 5 mbar i cmh20. the problem only occurs at peep values below 5 mbar i cmh20.
  • Action
    Drager urgently recommends that users immediately inspect any stock and dispose of any product (part number 5704964) with a date of manufacture up to and including 03-2016. A Free of charge replacement product can be obtained by following the instructions in the customer letter.

Device

Drager Ventstar Paediatric Circuit, used in conjunction with the Dräger Oxylog 3000plus Transport...

Manufacturer

Draeger Medical Australia Pty Ltd