Events

Retiro De Equipo (Recall) de INTELLIVUE - INFORMATION CENTER CLIENT

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
    55300
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-01-14
  • 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
    Users have replaced keyboards supplied or approved by philips with multi-media-type keyboards which have an audio volume adjustment and muting controls. this allows users to easily mute audio alarms on the intellivue information center or to reduce their volume. the alarm audio volume on beside monitors and client devices connected to the intellivue information center is not affected. although the service and installation guide includes warnings about the use of hardware and software not supplied by philips it does not specify that ignoring the warning can result in loss of alarm annunciation or in the impairment of central patient monitoring.

Device

INTELLIVUE - INFORMATION CENTER CLIENT
  • Modelo / Serial
    Model Catalog: M3151B (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3145 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3155 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3140 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3150A (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3153A (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3170 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3154 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Descripción del producto
    INTELLIVUE-INFORMATION CENTER CLIENT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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