Events

Rappel de PS500 External Power Supply Unit used 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-00165-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-02-18
  • 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-00165-1
  • 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 batteries installed in the ps500 deplete much earlier than expected although the battery indicator showed a sufficiently charged battery. in some cases neither the “battery low” nor the “battery depleted” alarm was given, when the remaining battery capacity fell below 10%. available data indicates that the charged battery will last for at least 3 minutes. in case of a main power loss, this 3 minute battery back-up should typically be sufficient until the emergency main power supply is re-established.
  • Action
    Draeger is advising users to only use the affected device for transport if absolutely necessary and users should not rely on the battery status indicator. Draeger is recommending users have a breathing bag available for manual ventilation as per the Instructions for Use (IFU). Draeger is advising that if the power fail alarm occurs during transport, provide manual ventilation and immediately connect the ventilator to wall power to resume ventilation. Draeger is advising that the batteries on all affected devices will be replaced as an interim correction, until a permanent fix can be developed.

Device

PS500 External Power Supply Unit used with Dräger V Series Ventilators

Manufacturer

Draeger Medical Australia Pty Ltd