Events

Rappel de PROPAQ LT MONITOR WITH WIRELESS RADIO

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par WELCH ALLYN CANADA LIMITED.

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
    43160
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-11-01
  • 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
    Fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could in rare instances potentially interrupt propaq lt device operations. if this unlikely event were to occur the device would either present an error screen instructing the user to restart the monitor or could instead present a blank or white screen. either screen would be accompanied by one or more blinking led lights and in either case the issue would be resolved by restarting (power cycling) the monitor. there is no risk associated with this issue other than a very short delay in obtaining patient vital signs from the propaq lt while the device is restarted.

Device

PROPAQ LT MONITOR WITH WIRELESS RADIO
  • Modèle / numéro de série
    Model Catalog: 802LTAN (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 802LT0N (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 802LTRN (Lot serial: > 10 NUMBERS CONTACT MFG)
  • Description du dispositif
    PROPAQ LT 802LTAN
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED