Events

Retiro De Equipo (Recall) de PHILIPS AVENT SMART EAR THERMOMETER

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
    25781
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-01-31
  • 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
    There is a possibility that a lay user obtains a body temperature value of a febrile patient that is lower than actual just missing the fever threshold. the lay user might not recognize a false negative fever measurement as inaccurate and base the decision not to seek help or not to treat solely on the reading of the device ignoring other possible symptoms of disease. this may lead to delayed treatment which might contribute to an injury or aggravation of the underlying disease. instructions for use instruct users of the ear thermometer sch740 on the way to take measurements including how to direct the device and keep the sensor tip clean which are most crucial aspects for obtaining a proper temperature reading. the users are cautioned that the values are for reference only and not a substitute for professional advice.

Device

PHILIPS AVENT SMART EAR THERMOMETER
  • Modelo / Serial
    Model Catalog: SCH740 (Lot serial: >1000 NUMBERS CONTACT MFG)
  • Descripción del producto
    PHILIPS AVENT SMART EAR THERMOMETER
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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