Events

Rappel de PATIENT DATA MODULE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    58986
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-08-27
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    The following issue is being addressed by ge healthcare file no. fmi 36107: 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. if your facility uses the pdm only with transport pro or solar monitors the issue does not exist.

Device

PATIENT DATA MODULE

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)