Events

Rappel de VERIS 8600 VITAL SIGNS MONITOR - ANESTHESIA SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BAYER MEDICAL CARE 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
    18203
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2013-11-20
  • 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
    The main board p/n 301641 installed in some medrad veris mr monitor units may be faulty and could lead to unexpected shutdown of the system while in use. this would result in the loss of vital signs information from the monitor. failure of the monitor may not only result in an inability of the user to view vital signs information but this failure may also go unrecognized. this may present an increased risk to patients who require that their vital signs be monitored while undergoing an mri exam such as those who are sedated anesthetized or who are on critical medications. thus it is required to continually monitor the system to ensure proper functioning.

Device

VERIS 8600 VITAL SIGNS MONITOR - ANESTHESIA SYSTEM
  • Modèle / numéro de série
    Model Catalog: 3011994 (Lot serial: 32889); Model Catalog: 3011996 (Lot serial: 32889); Model Catalog: 3011996 (Lot serial: 21470); Model Catalog: 3011994 (Lot serial: 21470); Model Catalog: 3011996W (Lot serial: 47118); Model Catalog: 3011996W (Lot serial: 300077); Model Catalog: 3011996W (Lot serial: 33810); Model Catalog: 3011996W (Lot serial: 33822); Model Catalog: 3011992 (Lot serial: 29694); Model Catalog: 3011992 (Lot serial: 25656); Model Catalog: 3011992 (Lot serial: 25655); Model Catalog: 3011994W (Lot serial: 37221); Model Catalog: 3011992W (Lot serial: 37012); Model Catalog: 3014268 (Lot serial: 36432); Model Catalog: 3011993 (Lot serial: 32902); Model Catalog: 3011993 (Lot serial: 33867); Model Catalog: 3011993 (Lot serial: 33870); Model Catalog: 3011994 (Lot serial: 29268); Model Catalog: 3011996 (Lot serial: 29268); Model Catalog: 3011994 (Lot serial: 34633); Model Catalog: 3011996 (Lot serial: 34633)
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    VERIS 8600 VITAL SIGNS MONITOR-ANESTHESIA SYSTEM
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

BAYER MEDICAL CARE INC.
  • Adresse du fabricant
    INDIANOLA
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    HC