Events

Rappel de ZEUS INFINITY EMPOWERED (ANESTHESIA WORKSTATION)

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par DRAEGER MEDICAL CANADA INC..

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
    126874
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-05-28
  • 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 device is designed to generate an audible and visual alarm when the measured value for spo2 falls below the alarm threshold set for the spo2 low alarm by the clinician. if the measured value continues to fall the device is designed to continue to generate a spo2 low alarm. but for devices with software version 1.03 if the sp02 measured value drops below the spo2 low alarm threshold by more than 10 percent the audible and visual alarm for sp02 low will stop. if the value measured rises again the alarm will be generated again as soon as the measured value is ten percent or less below the spo2-low alarm threshold. all displayed measurements of values and spo2 curves are performing as designed at any time.

Device

ZEUS INFINITY EMPOWERED (ANESTHESIA WORKSTATION)
  • Modèle / numéro de série
    Model Catalog: MK04000 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    ZEUS IE ANESTHESIA WORKSTATION
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.