Events

Rappel de XPER FLEX CARDIO PHYSIOMONITORING SYSTEM - MAIN UNIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PHILIPS ELECTRONICS LTD..

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
    62619
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-08-21
  • 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
    Because of intermittent communication between the host system and teh flex cardio it is possible for any of the following conditions to occur: - boom monitor (display) may not display all active waveform and/or vital sign data. - delayed audible and visual alarms at the flex cardio and boom monitor respectively due to a mismatch between the alarm limits on the host system and the flex cardio/boom monitor. - after patient admission and case initiation at the host system the case may not be fully transmitted to the flex cardio. in this case the boom monitor in the exam/procedure room will display vital sign data but the flex cardio will not provide audible alarms. - after patient discharge and case termination at the host system case termination may not be transmitted to the flex cardio. in this case the boom monitor in the exam/procedure room will continue to display vital sign data and the flex cardio will continue to provide audible alarms.

Device

XPER FLEX CARDIO PHYSIOMONITORING SYSTEM - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: FC2010 (Lot serial: >10 numbers contact mfg); Model Catalog: FC2020 (Lot serial: >10 numbers contact mfg)
  • Description du dispositif
    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM-MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Philips
  • Source
    HC