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
    145464
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-04-26
  • 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
    Over time low-frequency vibrations can cause the pins within the female connectors on the internal motor controller to data acquisition board ribbon cable to become partially displaced which causes momentary high resistance that interferes with data transfer. this may cause the ventilator to fail power on self testing (post) or cause continuous built in test (cbit) to detect a fault and lead to a ventilator shut down with alarm during use or during intra-hospital transport. if the v60 shuts down for any vent inop condition and is operating on battery power an audible high-priority alarm will sound continuously for at least 2 minutes. 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. the device may display an error code 100a 1006 1007 or 1008 on the screen. displaying one of these error codes indicates that the ventilator has had a communication failure that may be caused by the cable.

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