Events

Rappel de Draeger Evita V300 with optional PS500

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
    19463
  • Date de mise en oeuvre de l'événement
    2015-11-24
  • 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 cases in which the battery capacity of the optional ps500 of an iacs workstation critical care (evita infinity v500, evita v300 and babylog vn500 ventilators) was unexpectedly shortened. the batteries were discharged early, even though the device was indicating an adequate battery state of charge. the devices generate a "battery low" alarm, followed by "battery flat". in exceptional cases, the "battery flat" alarm might be displayed too late, or not at all. after complete discharge of the batteries, the device correctly alerts to failure of the power supply by the auxiliary alarm (piezo, power failure alarm) in all cases., current analysis of the battery data available indicates that an operating time of at least 20 minutes can normally be maintained after the device is disconnected from the power supply, which sufficiently bridges the gap in the event of a mains power failure until the emergency power supply can be activated.
  • Action
    Software to be upgraded

Device

Draeger Evita V300 with optional PS500
  • Modèle / numéro de série
    Model: Evita V300, Affected: With optional PS500 installed
  • Manufacturer
    Draegerwerk AG & Co KGaA

Manufacturer

Draegerwerk AG & Co KGaA