Events

Rappel de GE Carescape Bx50 Patient Monitor

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
    17251
  • Date de mise en oeuvre de l'événement
    2014-09-01
  • 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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    If the pdm is quickly disconnected and reconnected (a less than 10 second cycle) from a carescape bx50 monitor following a "patient discharge" or during active monitoring, the ecg waveform and its associated waveform parameters could be analyzed incorrectly., the ecg heart rate (hr) parameter data, the ecg waveform analysis and other ecg parameter measurements are displayed at values that will be less than the actual patient's physiologic condition. as a result of the abnormal analysis of data, the alarms for serious conditions may not be triggered appropriately. the issue potentially affects heart rate, ecg st segment analysis, 12 lead ecg analysis; ecg, spo2, respiration and invasive blood pressure waveforms both locally and at cic; and data displayed at cic may show data drop out. neither bedside nor cic data can reliably represent the parameters being measured.
  • Action
    Software to be upgraded

Device

GE Carescape Bx50 Patient Monitor

Manufacturer

GE Medical Systems Information Technologies