Events

Retiro De Equipo (Recall) de ECG OUT SYNC CABLE

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
    142706
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-11-07
  • 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
    Philips has become aware that when a philips monitor/defibrillator is receiving an ecg signal from an auxiliary bedside monitor via a sync cable the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (efts) while connected to ac power: - on the heartstart mrx and heartstart xl eft noise can be misinterpreted as an r-wave - on the heartstart xl+ eft noise can disable ecg monitoring and potentially interrupt demand mode pacing*. 1. *note: it is contrary to the instructions in the xl+ instructions for use (ifu) to perform demand mode pacing while using the sync cable to provide the ecg signal from a beside monitor. the xl+ ifu includes the following warning: "when pacing in demand mode the ecg cable from the patient must be directly connected to the heartstart xl+." if the user follows this warning this problem cannot occur on the xl+.

Device

ECG OUT SYNC CABLE
  • Modelo / Serial
    Model Catalog: M1783A (Lot serial: ALL); Model Catalog: M5526A (Lot serial: ALL); Model Catalog: M3536A (Lot serial: ALL); Model Catalog: M3535A (Lot serial: ALL); Model Catalog: M4735A (Lot serial: ALL); Model Catalog: 861290 (Lot serial: ALL)
  • Descripción del producto
    ECG OUT SYNC CABLE
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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