Events

Rappel de 3600 MONOPLACE HYPERBARIC CHAMBERS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SECHRIST INDUSTRIES 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
    104024
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2012-10-26
  • 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
    Three issues were identified with these units. these include locking up of the display / control panel when the chamber is first turned on. this prevents initial operation of the chamber. the condition can be cleared by temporarily unplugging the chamber from the wall power source and disconnecting the battery back-up. this resets the control panel. once this is performed the chamber can continue to be used. the second is the chamber going into the safe state condition during treatment when the operator has touched or adjusted the controls. after completion of decompression in the safe state mode the treatment can be resumed. following the safe state initiation an inspection of the chamber does not indicate any anomaly that would result in the initiation of a safe state condition. the third issue involves the chamber automatically going into a safe state condition during treatment on its own without any operator action. following the safe state initiation an inspection of the chamber fails to indicate any anomaly that would result in the initiation of a safe state condition. no reports of injuries or death reported.

Device

3600 MONOPLACE HYPERBARIC CHAMBERS
  • Modèle / numéro de série
    Model Catalog: 3600ER (Lot serial: 360029); Model Catalog: 3600E (Lot serial: 360032); Model Catalog: 3600E (Lot serial: 360029); Model Catalog: 3600ER (Lot serial: 360032)
  • Description du dispositif
    Monoplace 3600 Hyperbaric Chambers
  • Manufacturer
    SECHRIST INDUSTRIES INC.

Manufacturer

SECHRIST INDUSTRIES INC.