Events

Rappel de Oxylog 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-2015-RN-01256-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-12-23
  • 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-01256-1
  • 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
    Some cases have been reported to draeger in which the "poti unplugged" error message was generated. in those cases an audible and visual alarm is generated, the breathing system releases pressure and the ventilation function stops operating. the error message is caused by increased electrical contact resistances of the controllers (setting potentiometers). the increased resistance is caused by an oxide layer that has formed on the controller over a lengthy period of time. no patient injury has been reported due to this issue.
  • Action
    The oxide layer can only form if the controllers are rarely or never moved and according to product monitoring, some users never, or rarely, use the FiO2 controller. As a preventative measure to ensure the resistance taper of the controllers are sufficiently cleaned, Draeger is recommending the following addition to the daily device check: - Prior to turning on the Oxylog in readiness to conduct the daily device check, the staff member turns each of the controllers (Vt, RR, Pmax and FiO2) to the right and left stop positions (minimum and maximum values) at least ten times each. - The Oxylog can then be turned on and the onboard device check completed.

Device

Oxylog Transport Ventilator

Manufacturer

Draeger Medical Australia Pty Ltd