Events

Rappel de CONTOURA BARIATRIC BED

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ARJO CANADA 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
    76744
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-10-08
  • 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 contoura 1000/1080 range beds are intended to be used as a bariatric medical device which is designed for patients with bmi >40. the devices have been made in accordance to the specification and cannot be descibed as defective. however if the device is used in contradiction to its intended use there is a low but existing entrapment risk for a patient being treated on this bed while being under this bmi level as not all patients are at equal risk for entrapment. in particular small lightweight patients are generally at the greatest risk for entrapment because their small physical dimensions may enhance their ability to fit into a gap in whole or in part. to help the users of these devices to always be aware of the intended use and therefore increase safety we offer additional labeling indicating that the bed is designed for patients with bmi >40. the instruction for use will contain more details on the issue and additional labels will be placed on the bed frame.

Device

CONTOURA BARIATRIC BED
  • Modèle / numéro de série
    Model Catalog: C1000 (Lot serial: ); Model Catalog: C1080 (Lot serial: )
  • Description du dispositif
    CONTOURA BARIATRIC BED
  • Manufacturer
    ARJO CANADA INC.

Manufacturer

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