Events

Retiro De Equipo (Recall) de MAGNUS Hybrid OR table column 1180.01B2

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-2015-RN-00466-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-02
  • 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-00466-1
  • 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
    Maquet have been made aware of a complaint regarding a reported collision between the c-arm of the angiography-system and the magnus or table system. the root cause analysis has shown that the magnus column provided the wrong position data for the longitudinal movement. thus the collision calculation of the angiography-system led to an incorrect result. it was diagnosed that the magnus or table system may provide incorrect position data for particular movements in very rare cases after switching on the angiography-system. if this occurs, the system at the latest operates properly again after activating the corresponding movement.
  • Acción
    A MAQUET service technician will be contacting users to arrange an appointment to update the software free of charge. Until that occurs users should activate all movements of the OR table system for a short time after switching on the angiography-system. The operator always has to observe the movement of the C-arm to have the possibility to react early enough if required.

Device

MAGNUS Hybrid OR table column 1180.01B2
  • Modelo / Serial
    MAGNUS Hybrid OR table column 1180.01B2Serial number 00001 to 00100
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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