Events

Rappel de Draeger Evita V500 Ventilator, with optional PS500 installed

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Draegerwerk AG & Co KGaA.

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
    18826
  • Date de mise en oeuvre de l'événement
    2015-07-08
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • Cause
    Draeger has become aware of an event in which the battery capacity of the optional ps500 of an iacs workstation critical care (evita infinity v500, evita v300 and babylog vn500 ventilators) did not last as long as expected. the batteries installed in the ps500 depleted much earlier than expected although the battery indicator showed a sufficiently charged battery. the sequential alarms, "battery low" followed by" battery depleted" were given, however, the remaining time until the ventilator shut down was not foreseeable. when the battery depleted totally, the power fail alarm was generated.
  • Action
    Product to be modified

Device

Draeger Evita V500 Ventilator, with optional PS500 installed

Manufacturer

Draegerwerk AG & Co KGaA