Events

Rappel de LIFE PULSE HIGH FREQUENCY JET VENTILATOR WITH PATIENT BOX

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BUNNELL 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
    72298
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2012-12-19
  • 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
    A specific lot of heater wire insulation may fail by melting causing sparking and smoking. the resulting circuit failure could result in patient injury or death.

Device

LIFE PULSE HIGH FREQUENCY JET VENTILATOR WITH PATIENT BOX
  • Modèle / numéro de série
    Model Catalog: 937 (Lot serial: 12H349); Model Catalog: 937 (Lot serial: 12H330); Model Catalog: 937 (Lot serial: 12I362); Model Catalog: 937 (Lot serial: 12I371); Model Catalog: 937 (Lot serial: 12I397); Model Catalog: 937 (Lot serial: 12J413); Model Catalog: 937 (Lot serial: 12J430); Model Catalog: 937 (Lot serial: 12J448); Model Catalog: 937 (Lot serial: 12K457); Model Catalog: 937 (Lot serial: 12K471); Model Catalog: 937 (Lot serial: 12C092); Model Catalog: 937 (Lot serial: 12C102); Model Catalog: 937 (Lot serial: 12C115); Model Catalog: 937 (Lot serial: 12C136); Model Catalog: 937 (Lot serial: 12D159); Model Catalog: 937 (Lot serial: 12D172); Model Catalog: 937 (Lot serial: 12C125); Model Catalog: 937 (Lot serial: 12D189); Model Catalog: 937 (Lot serial: 12E204); Model Catalog: 937 (Lot serial: 12E211); Model Catalog: 937 (Lot serial: 12F241); Model Catalog: 937 (Lot serial: 12F254); Model Catalog: 937 (Lot serial: 12F271); Model Catalog: 937 (Lot serial: 12G279); Model Catalog: 937 (Lot serial: 12G321)
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    LIFE PULSE PATIENT CIRCUITS
  • Manufacturer
    BUNNELL INC

Manufacturer

BUNNELL INC