Events

Retiro De Equipo (Recall) de INTELLIVUE PATIENT MONITOR MP5T

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
    22204
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-09-30
  • 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 become aware that in time-synchronized automatic/sequence mode the nbp automatic measurement series is stopped inadvertently if the repetition interval is increased manually by the user (e.G. from 5 to 15 minutes) in between two consecutive measurements: - a prompt message "any ongoing nbp measurement and automatic cycle stopped" is displayed and a single tone sounds when the measurement series is stopped. - after the automated measurement series has been stopped nbp numeric repetition time and time to next measurement are no longer displayed i.E. the nbp numeric field is blank.

Device

INTELLIVUE PATIENT MONITOR MP5T
  • Modelo / Serial
    Model Catalog: M8105AT (Lot serial: DE21008390); Model Catalog: M8105AT (Lot serial: DE21008383); Model Catalog: M8105A (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: M8105AS (Lot serial: DE47004280)
  • Descripción del producto
    INTELLIVUE PATIENT MONITOR MP5T
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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