Events

Retiro De Equipo (Recall) de Dräger Fabius Anaesthesia Machine Device's : Fabius Plus XL, Fabius Tiro, Fabius Tiro, Fabius GS Premium, Fabius Plus XL

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 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-2018-RN-00158-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-02-27
  • 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-2018-RN-00158-1
  • 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
    Dräger has become aware of one case where the automatic ventilation failed during the operation of a fabius unit. this was due to the motor moving beyond the upper position and thereby damaging the ventilator cover. ventilation of the patient could reportedly be continued by means of the manspont mode and a manual resuscitator.No serious injury has been reported to date.As a precaution drager will be updating relevant units.
  • Acción
    Drager is advising they are currently producing replacement motors for the potentially affected devices. Dräger Service have ordered the replacement motor(s) and on receipt of the part from Germany, will contact the Biomedical Engineering team to arrange free of charge, the installation and testing of the replacement motor. In the interim, users may continue to operate the anaesthesia device with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for Use.

Device

Dräger Fabius Anaesthesia Machine Device's : Fabius Plus XL, Fabius Tiro, Fabius Tiro, Fabius GS ...
  • Modelo / Serial
    Dräger Fabius Anaesthesia MachineDevice's : Fabius Plus XL, Fabius Tiro, Fabius Tiro, Fabius GS Premium, Fabius Plus XLSerial Number's :ASKM-0047, ASKH-0027, ASKH-0168, ASKH-0140, ASKM-0246ARTG Number: 104223Draeger Australia - Anaesthesia system
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd