Events

Retiro De Equipo (Recall) de Neuromuscular Transmission Module used with Carescape and Datex-Ohmeda S/5 Anaesthesia monitors

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00179-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-19
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00179-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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