Events

Retiro De Equipo (Recall) de ZEUS INFINITY EMPOWERED (ANESTHESIA WORKSTATION)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por DRAEGER MEDICAL CANADA 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
    126874
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-05-28
  • 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 device is designed to generate an audible and visual alarm when the measured value for spo2 falls below the alarm threshold set for the spo2 low alarm by the clinician. if the measured value continues to fall the device is designed to continue to generate a spo2 low alarm. but for devices with software version 1.03 if the sp02 measured value drops below the spo2 low alarm threshold by more than 10 percent the audible and visual alarm for sp02 low will stop. if the value measured rises again the alarm will be generated again as soon as the measured value is ten percent or less below the spo2-low alarm threshold. all displayed measurements of values and spo2 curves are performing as designed at any time.

Device

ZEUS INFINITY EMPOWERED (ANESTHESIA WORKSTATION)
  • Modelo / Serial
    Model Catalog: MK04000 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    ZEUS IE ANESTHESIA WORKSTATION
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Stefan Dräger GmbH
  • Source
    HC