Events

Retiro De Equipo (Recall) de XPER FLEX CARDIO PHYSIOMONITORING SYSTEM - MAIN UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHILIPS ELECTRONICS LTD..

¿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
    62619
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-08-21
  • 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
    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
  • Modelo / Serial
    Model Catalog: FC2010 (Lot serial: >10 numbers contact mfg); Model Catalog: FC2020 (Lot serial: >10 numbers contact mfg)
  • Descripción del producto
    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM-MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    HC