Events

Rappel de Neuromuscular Transmission Module used with Carescape and Datex-Ohmeda S/5 Anaesthesia monitors

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-2014-RN-00179-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-02-19
  • 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-2014-RN-00179-1
  • 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
    When the e-nmt-01 module is used in conjunction with the electrosensor, the neuromuscular transmission (nmt) values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. in the clinical situation visual movements of the hand are seen after tof (train of four) stimulation, but the patient shows no counts, or counts are not corresponding to the actual amount of movements. this issue may lead to an inadequate dose of muscle relaxants. this issue may occur when the e-nmt-01 module is plugged into the carescape or the datex-ohmeda s/5 anesthesia monitor. module e-nmt-00 is unaffected by this issue.
  • Action
    GE Healthcare is advising users to do not use the E-NMT-01 module with ElectroSensor. The E-NMT-01 module can continued to be used with the MechanoSensor and Paediatric MechanoSensor. A software update will be provided to all affected users as a permanent correction. This action has been closed-out on 10/02/2016.

Device

Neuromuscular Transmission Module used with Carescape and Datex-Ohmeda S/5 Anaesthesia monitors
  • Modèle / numéro de série
    Neuromuscular Transmission Module used with Carescape and Datex-Ohmeda S/5 Anaesthesia monitors Module Version: E-NMT-01ARTG Number: 140216
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd