Events

Retiro De Equipo (Recall) de Tegris OR Table Control (Operating room device management system)

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-2014-RN-00917-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-20
  • 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-00917-1
  • 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 has identified a potential issue that might occur with the tegris software module for operating room (or) table integration. the fault is only relevant for customers with a license for the or table control 1703.35a0 module and use it to integrate the magnus operating table system.The button commands for "lower leg up" and "leg down" have been switched in the software for the integration of the magnus operating table system. as a result, when these functions are activated on the tegris touchscreen, the wrong movement is executed. thus far, no incidence has been reported in which a person has been injured or endangered.
  • Acción
    Maquet Australia is advising the customers to discontinue using the Tegris OR Table Control in conjunction with MAGNUS that is equipped with a software version up to 2.1.x.x,. The problem has been resolved as of version 2.2.x.x. A Maquet Service Technician will provide a software update to resolve this issue. This action has been closed-out on 18/03/2016.

Device

Tegris OR Table Control (Operating room device management system)
  • Modelo / Serial
    Tegris OR Table Control (Operating room device management system)Part number: 1703.35A0All software versions up to 2.1.x.x are affectedARTG Number: 185134
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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