Rappel de GE Patient Monitor Multiparameter

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 GE Medical Systems Information Technologies.

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
    15471
  • Date de mise en oeuvre de l'événement
    2013-10-02
  • Pays de l'événement
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
  • 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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    Ge healthcare has recently become aware of a potential safety issue due to ecg filter settings associated with the b20/b40 v1, b30 and b40 v2 patient monitors. the b20, b30 and b40 patient monitors set the ecg filter setting incorrectly if the monitor starts with impedance respiration set in the on position. instead of the user selected filter, an additional 0.5 hz high pass filter is used. the additional 0.5 hz high pass filter causes changes to the ecg waveform morphology and incorrect display of st values. the st-elevation measurement can be under estimated in this situation and therefore the treatment of the patient can be delayed.
  • Action
    Software to be upgraded

Device

Manufacturer