Events

Retiro De Equipo (Recall) de VERIS 8600 VITAL SIGNS MONITOR - ANESTHESIA SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BAYER MEDICAL CARE INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    18203
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2013-11-20
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    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)
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    VERIS 8600 VITAL SIGNS MONITOR-ANESTHESIA SYSTEM
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

BAYER MEDICAL CARE INC.
  • Dirección del fabricante
    INDIANOLA
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    HC