Events

Retiro De Equipo (Recall) de Weinmann Medumat Transport Ventilator

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet 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-2013-RN-01126-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-11-01
  • 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-2013-RN-01126-1
  • 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
    The manufacturer, weinmann emergency, has identified a potential issue that could result in an undefined operating state of the medumat transport ventilator. in some cases an interaction between internal structural components and sensors for internal device monitoring can cause an undefined operating state resulting in the device displaying a "device malfunction" error.
  • Acción
    Maquet is advising users to switch the machine off and on again in the case of the error message "device malfunction". This will suspend running ventilation for approximately 30 seconds. Maquet is providing a software update to eliminate incorrect "Device Malfunction" errors. Users should note that any "Device Malfunction" errors after the installation of the software update are valid.

Device

Weinmann Medumat Transport Ventilator
  • Modelo / Serial
    Weinmann Medumat Transport VentilatorAll serial numbersARTG Number: 190246
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA