Events

Retiro De Equipo (Recall) de MAQUET operating table accessories with Accessory Adaptor 600525A0 Manufactured from 2002 onwards

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-01225-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-15
  • 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-01225-1
  • 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 accessory adaptor (600525a0) is designed for the mounting of maquet accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment. the accessory adapter is used with the magnus table back plates to attach the horseshoe head rest or the skull clamp. maquet has been notified of a case where a head rest was levered out of the dovetail profile of the accessory adaptor. it was identified that the raw material of the accessory adaptor did not meet maquet specifications. while the accessory adapter does carry the specified weight of 11kg at a distance of 300mm, the tensile and flexural strength of the material was less than specification.There is a very rare possibility should the attached accessory release from the adapter without warning during a surgical procedure that the patient may sustain a cervical spine injury. to date no incident has been reported in which a person was injured.
  • Acción
    MAQUET will be contacting customers to provide a new replacement Accessory Adaptor (600525A0). Until the replacement has been provided, MAQUET is advising users that Accessory Adaptor (600525A0) should not be used.

Device

MAQUET operating table accessories with Accessory Adaptor 600525A0 Manufactured from 2002 onwards
  • Modelo / Serial
    MAQUET operating table accessories with Accessory Adaptor 600525A0 Manufactured from 2002 onwardsARTG Number: 163023
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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