Events

Rappel de B20, B30, B40 Patient Monitors (used for ECG monitoring)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia Pty Ltd.

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
    RC-2013-RN-01027-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-10-02
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01027-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    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 treatment of the patient can be delayed.Please note that there is no issue when the monitor starts with impedance respiration set in the off position.
  • Action
    GE Healthcare is providing users with work around instructions to follow until a software correction is available.

Device

B20, B30, B40 Patient Monitors (used for ECG monitoring)
  • Modèle / numéro de série
    B20, B30, B40 Patient Monitors (used for ECG monitoring)Serial Numbers: B20 - SGF11030001WA to SGF13176741WA (software version 1)B30 - SF309380033WA to SF313177120WA (software version 2)B40 - SG211210001WA to SG213172146WA (software version 1)B40 - SJF13010005WA to SJF13180144WA (software version 2)ARTG Number: 92726
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd