Events

Rappel de Draeger Babylog VN500 Ventilator

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
    19774
  • Date de mise en oeuvre de l'événement
    2016-02-19
  • 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
    Manufacturer has become aware of cases in which the battery capacity of the optional ps500 power supply unit for the evita infinity v500, evita infinity v300 and the babylog vn500 was rapidly and unexpectedly reduced despite using the most recent power supply firmware (fw1 .50) which was released in november 2015. the batteries prematurely discharged, even though an adequate battery charge status was displayed on the device. the "battery discharged" alarm was not in all cases triggered five minutes prior to battery discharge, as specified. when the batteries were completely discharged, the devices triggered the existing power failure alarm correctly. given these new findings, the decision has been made to cancel the distribution of the updated power supply firmware (fw1.50) and to roll back devices on which this firmware version is already installed to fw1.49.
  • Action
    Product to be exchanged

Device

Draeger Babylog VN500 Ventilator

Manufacturer

Draegerwerk AG & Co KGaA