Events

Retiro De Equipo (Recall) de CARESCAPE MONITOR B850 SYSTEM - C1 CPU W/THIRD VIDEO

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿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
    18137
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-05-29
  • 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 monitor may enter into a constant boot loop causing it to reboot continuously and will cause loss of overall monitoring and may lead to delayed treatment. when the usb cable connected to the carescape monitor b850 cpu or display is insecurely connected or faulty and is able to move the monitor may reboot. reboot may also happen if the display is continuously set on and off several times. the reboot will cause loss of overall monitoring and may lead to delayed treatment. there is a remote printing issue with currently printing prn 50 recorder. if the recorder prn 50 is currently printing when carescape monitor b850 sends printing request to that prn 50 the printing will be saved only after 12 seconds. the print job will be printed after the printer is ready if the waiting time is less than 30 seconds. b) when the user starts the printing from cic pro to the prn 50 located at the cic pro the printing jobs are printed locally at the bedside if the network prn 50 is busy. the monitor reboots due to an x server freeze and may reboot when the monitor is viewed from cic pro or when the printing is initiated from cic pro.

Device

CARESCAPE MONITOR B850 SYSTEM - C1 CPU W/THIRD VIDEO

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)