Events

Retiro De Equipo (Recall) de AVALON FETAL MONITOR FM20 - 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
    9893
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-06-10
  • 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
    This problem affects revision c and d of the software. in rare circumstances the settings for paper scale type and recorder speed may revert back to the factory default settings which are: us paper style and 3 cm/min paper speed. this behaviour would have the most impact in europe and asia/pacific where other settings are preferred. if this change remains undectected by the user it may lead to misinterpretation of the fetal trace and potential incorrect clinical decisions regarding patient care. the problem occurs when the power-up/boot sequence of the fetal monitor is interrupted e.G. switching the monitor off or unplugging the power cord before it has completed the boot sequence and switching it on again immediately (within 60 sec) after the interruption.

Device

AVALON FETAL MONITOR FM20 - MAIN UNIT
  • Modelo / Serial
    Model Catalog: M2702A (Lot serial: DE53001002 THROUGH DE53107383); Model Catalog: M2703A (Lot serial: DE53001002 THROUGH DE53107383)
  • Descripción del producto
    AVALON FETAL MONITOR FM20-MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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