Events

Retiro De Equipo (Recall) de YUNO Extension Device (used to support and stabilise the patient's body during a surgical procedure)

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-2012-RN-01151-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-14
  • 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-2012-RN-01151-1
  • 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 with the release lever of the screw tension mechanism, whereby it may be difficult to set or maintain the desired traction. this issue can occur during use with any patient population, however it is most likely to occur when setting higher tensions.
  • Acción
    A Maquet authorised Service Engineer is to arrange an appointment to assess the affected devices and to replace the release lever. Customers are advised to be aware that they may experience difficulty with the tension mechanism until the repair/replacement activity is performed.

Device

YUNO Extension Device (used to support and stabilise the patient's body during a surgical procedure)
  • Modelo / Serial
    YUNO Extension Device (used to support and stabilise the patient's body during a surgical procedure)Part Number: 1433.62A1; Serial number: 001-107Part Number: 1433.62A0; All serial numbersARTG Number: 163023
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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