Events

Retiro De Equipo (Recall) de Remote controls for JUPITER, ARTIS and TruSystem 7500 operating tables

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Trumpf Med Aust 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-00182-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-13
  • 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-00182-1
  • 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
    Trumpf medical received reports that the operating tables sporadically moved independently and without the user deliberately pressing an operating element. no patients or users were injured. the investigations determined that the root cause was a button on a remote control which was mechanically damaged by external influences. as a result of the damaged button, specific vibrations or movements of the remote control can emit a valid movement command at any time, either continuously or sporadically.This action was undertaken prior to the notification to the tga.
  • Acción
    Trumpf Medical is providing instructions as a supplement to the user manual and requesting the users to check the remote controls for visual damages.Trumpf Medical is requesting the customers to avoid using the remotes with visual damages to the key pads.Trumpf Medical is arranging the upgrade of the existing remote controls with a redesigned membrane keypad to eliminate the known mode of failure. This action has been closed-out on 19/02/2016.

Device

Remote controls for JUPITER, ARTIS and TruSystem 7500 operating tables
  • Modelo / Serial
    Remote controls for JUPITER, ARTIS and TruSystem 7500 operating tables
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd