Events

Retiro De Equipo (Recall) de AVALON FETAL MONITOR FM30 - 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
    52740
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-12-18
  • 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
    Philips has received a number of complaints of inaccurate ultrasound-derived fetal heart rate readings from users of the philips avalon fetal monitors (models fm20 fm30 fm40 and fm50). although the types of inaccuracies described in these complaints reflect known limitations inherent to ultrasound fetal heart rate monitoring the frequency of such complaints is greater for these devices than for the previous-generation philips series 50 fetal monitors. clinical decisions based on unrecognized inaccuracies in fetal heart traces may lead health care professionals to perform unnecessary interventions such as caesarean delivery fail to identify the need for interventions or fail to identify fetal distress.

Device

AVALON FETAL MONITOR FM30 - MAIN UNIT
  • Modelo / Serial
    Model Catalog: M2703A (Lot serial: > 100 Numbers contact mfg); Model Catalog: M2704A (Lot serial: DE81001152); Model Catalog: M2702A (Lot serial: > 10 numbers contact mfg); Model Catalog: M2705A (Lot serial: > 10 numbers contact mfg)
  • Descripción del producto
    AVALON FETAL MONITOR FM30 - MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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