Events

Retiro De Equipo (Recall) de FIXTURE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MAQUET-DYNAMED INC..

¿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
    134122
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-07-20
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The fixture (1002.65a0) is designed as a connecting element for the support and positioning of the patient's head on a maquet or table immediately before during and after surgical interventions as well as for examination and treatment. the fixture is used to adapt a range of different head rests and horseshoe head rests with a central square mount. as part of post market surveillance cases have been reported to maquet gmbh which showed the welded joint between square mount and the first fixable swivel joint broke. this joint must bear the highest loads of all welded joints due to the cantilever. it is likely that the breakage had been caused by a poor welding joint in addition to rough handling and multiple overload by the user respectively. if the weld seam breaks during a procedure a serious injury cannot be ruled out.

Device

FIXTURE
  • Modelo / Serial
    Model Catalog: 1002.65A0 (Lot serial: NA)
  • Descripción del producto
    Fixture 1002.65A0
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    HC