Events

Retiro De Equipo (Recall) de Secondary 19" Touchscreen - TEGRIS System (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-2013-RN-00851-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-09
  • 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-00851-1
  • 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
    A tegris system that has a second touch monitor used to operate the operating room (or) table, is not equipped with an emergency stop button. in an unlikely event of malfunction of the table control module, which could lead to unexpected movement of the or table, this secondary touch monitor could not be used to stop the table in an emergency situation. thus, the intended immediate stop of the table movement could be delayed.
  • Acción
    Maquet is providing instructions to the user to disconnect both the primary and secondary touch screens from the OR table. The table can still be controlled by the corded or infrared hand control. A second emergency stop button will be installed on all existing and future secondary touch screens, which will be available in Australia in October 2013.

Device

Secondary 19" Touchscreen - TEGRIS System (Operating room device management system)
  • Modelo / Serial
    Secondary 19" Touchscreen - TEGRIS System (Operating room device management system)Part number: 1707.05A0ARTG number: 185134
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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