Events

Rappel de Optional PS500 External Power Supply Unit Used in connection with Dräger V Series Ventilators

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-2014-RN-00989-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-09-15
  • 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-2014-RN-00989-1
  • 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
    Draeger has advised that in some cases in which the battery capacity of the optional ps500 power supply unity of the infinity acs workstation critical care (evita infinity v500) has reduced unexpectedly. the batteries in the ps500 were discharged prematurely, even though adequate battery charge status was displayed on the device. as a consequence of this, draeger published a safety alert in february 2014, as well as a safety recall and the suspension of deliveries for devices using the ps500.
  • Action
    All PS500 Power Supply Units currently in use are in the process of being upgraded by the Dräger Service Engineers free of charge. A service-charging algorithm will be implemented, which prevents the problem of sulfation of the batteries, which was identified as a main reason for the reduction of the PS500 battery capacity.

Device

Optional PS500 External Power Supply Unit Used in connection with Dräger V Series Ventilators
  • Modèle / numéro de série
    Optional PS500 External Power Supply Unit Used in connection with Dräger V Series VentilatorsModels: Infinity V500; Babylog VN500; Evita V300ARTG Number: 158739
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd