Events

Rappel de ROOMER S

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par HUMAN CARE 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
    45051
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-11-05
  • 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
    Two identified problems that human care has decided to address. the first problem is related to a fixation screw on the telescopic hanger bar used on recalled device. this screw is located inside the unit hence not visible from the outside. a minor number of units have been detected where the level of loctite applied to the screw during manufacturing has been insufficient. this can cause the telescopic hanger bar to lose from its position and in a worst case fall out of its position. the second problem is related to the swivel hooks on the telescopic hanger bar. it has come to human cares attention that if the telescopic hanger bar is incorrectly used namely the swivel hooks on the hanger bar is faulty positioned before a patient transfer this can cause the sling out of its position which can result in a hazard to the user. it is important that the user manual is followed and that the hanger bar and its hooks are adjusted and positioned correctly prior to any patient transfer.

Device

ROOMER S
  • Modèle / numéro de série
    Model Catalog: 55300-XX (Lot serial: 32578510009); Model Catalog: 55300-XX (Lot serial: 32578510006); Model Catalog: 55220-XX (Lot serial: >10 lot numbers contact mfg); Model Catalog: 55210-XX (Lot serial: >10 lot numbers contact mfg); Model Catalog: 55200-XX (Lot serial: >10 lot numbers contact mfg)
  • Description du dispositif
    ROOMER S
  • Manufacturer
    HUMAN CARE CANADA INC.

Manufacturer

HUMAN CARE CANADA INC.