Events

Rappel de ALARIS SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CAREFUSION 303 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
    108315
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-11-08
  • 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
    A problem with the power supply board used with the alaris pc unit model 8015 only. a component on this power supply board is drawing extra charge and depleting the battery sooner than expected. the initial low battery message/ alarm will indicate that the battery has less than 30 minutes before depletion. however the battery power may not be available for the time indicated. if an affected power supply board is used in a pc unit the battery may not last as indicated by the low battery message/alarm. if the pc unit is not plugged into an a/c outlet as soon as the low battery message appears this could stop infusion or delay therapy which may result in serious injury and/or death.

Device

ALARIS SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER
  • Modèle / numéro de série
    Model Catalog: TC10005122 (Lot serial: n/a)
  • Description du dispositif
    Alaris PC Model 8015
  • Manufacturer
    CAREFUSION 303 INC.

Manufacturer

CAREFUSION 303 INC.