Events

Rappel de FIXTURE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MAQUET-DYNAMED INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    134122
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-07-20
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    Model Catalog: 1002.65A0 (Lot serial: NA)
  • Description du dispositif
    Fixture 1002.65A0
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    HC