Events

Rappel de LifePoint bPLUS

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 Metsis Medikal Ltd Sti.

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
    21574
  • Date de mise en oeuvre de l'événement
    2017-06-22
  • 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: Total Safety Solutions Ltd, 19 Bridgehead Cove, Hobsonville, Auckland 0618
  • Cause
    As a result of the momentary communication interruption caused by the software of automatic external defibrillator devices during the self-test procedure, the device got stuck in stand-by during this process and the bios battery was depleted then the device was locked-up due to processor being subjected to low supply voltage during depletion of bios battery and the warning indicator was stuck in green, not switching to red by full depletion of bios battery. the self-test is performed by the main processor and cannot control the indicator position in the event of possible instantaneous communication and lockup problems.
  • Action
    Software to be upgraded

Device

LifePoint bPLUS
  • Modèle / numéro de série
    Model: , Affected: Models: LifePoint Pro, LifePoint bPLUS, LifePoint mPLUS
  • Manufacturer
    Metsis Medikal Ltd Sti

Manufacturer

Metsis Medikal Ltd Sti