Events

Retiro De Equipo (Recall) de V60 VENTILATOR SYMBOLS ONLY WITH CFLEX AND AVAPS OPTIONS

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
    90376
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-02-07
  • 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
    The v60 ventilator with version 2.20 software installed may falsely detect that the blower motor has stalled. if this condition occurs the software will cause the ventilator to shut down (vent inop) and display error code 100e. ventilatory support will cease. an audible high-priority alarm will sound continuously for at least 2 minutes when the v60 shuts down for any vent inop condition and is operating on battery power. if the v60 is connected to ac power (mains supply) the alarm will continue to sound until an operator intervenes. if the v60 is connected to a remote alarm system the alarm system will be activated until action is taken by the operator. error code 100e only exists in v60 version 2.20 software. therefore v60's running version 2.10 software are not subject to this particular vent inop condition. an audible high-priority alarm will sound continuously for at least 2 minutes when the v60 shuts down for any vent inop condition and is operating on battery power. if the v60 is connected to ac power (mains supply) the alarm will continue to sound until an operator intervenes. if the v60 is connected to a remote alarm system the alarm system will be activated until action is taken by the operator. error code 100e only exists in v60 version 2.20 software. therefore v60's running version 2.10 software are not subject to this particular vent inop condition.

Device

V60 VENTILATOR SYMBOLS ONLY WITH CFLEX AND AVAPS OPTIONS
  • Modelo / Serial
    Model Catalog: 1053614 (Lot serial: ALL)
  • Descripción del producto
    V60 VENTILATOR SYMBOLS ONLY WITH CFLEX AND AVAPS OPTIONS
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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