Events

Retiro De Equipo (Recall) de Drager Fabius MRI Anaesthesia Machine

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Draeger Medical 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-2015-RN-00535-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-06-19
  • 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-2015-RN-00535-1
  • 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
    Drager became aware of cases in which the fabius mri or parts of the system were attracted by the magnetic field of the mri. if the fabius mri is positioned too close to the mri, the magnetic force of the mri can loosen parts of the fabius mri and cause personal injury.
  • Acción
    Drager Medical is updating the Instructions for Use Manual and the device labelling clearly state that the device must only be used in areas where the field intensity is no more than 40 mTesla. Additionally, the ventilator door will be altered to include another lock in addition to the existing locking mechanism. This action has been closed-out on 15/08/2016.

Device

Drager Fabius MRI Anaesthesia Machine

Manufacturer

Draeger Medical Australia Pty Ltd