Events

Retiro De Equipo (Recall) de Maquet Operating Table with Fixture 1002.65AO Manufactured in the period between 2009 and 2013

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-2016-RN-00984-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-07-22
  • 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-2016-RN-00984-1
  • 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 fixture (1002.65ao) is designed as a connecting element for the support and positioning of the patient’s head on a maquet operating table immediately before, during and after surgical interventions and as for examination and treatment. the fixture is used to adapt a range of different head rest and horseshoe head rests with a central square mount. post market surveillance reported that the welded joint between the square mount and the first fixable swivel joint had broken. as a cantilever design, this joint must bear the highest load of all welded joints. it has been determined that the breakage had been caused by ineffective welding in addition to rough handling and multiple overloading. serious injury to the patient's cervical spine may occur if the weld seam breaks during a procedure. there have been no reports of injuries as a result of this issue.
  • Acción
    A Maquet service technician will be contacting customers to arrange an appointment to carry out replacement of all associated components. Until the replacement has been performed, users are advised that the device should be inspected for damage before every use. In this context, particular attention should be paid to the potential for cracks at the weld in the area illustrated in the customer letter. In case of doubt, customers are advised not to use the fixture. This action has been closed-out on 26/05/2017.

Device

Maquet Operating Table with Fixture 1002.65AO Manufactured in the period between 2009 and 2013
  • Modelo / Serial
    Maquet Operating Table with Fixture 1002.65AO Manufactured in the period between 2009 and 2013ARTG Number: 163023
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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