Retiro De Equipo (Recall) de Device Recall ECG Out Cable

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Philips Electronics North America Corporation.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Causa
    Issue with ecg out cables. when a philips monitor/defibrillator is receiving an ecg signal from an auxiliary bedside monitor via a sync cable or ecg out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (efts): " on the heartstart mrx and heartstart xl, eft noise may be misinterpreted as an r-wave. " on the heartstart xl+, eft noise can disable ecg monitoring and potentially interrupt demand mode pacing*. *note: it is contrary to the xl+ instructions for use to perform demand mode pacing while using the ecg out cable or obtaining the ecg signal from a bedside monitor. the xl+ instructions for use 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+.
  • Acción
    Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Customers should remove affected sync cables and ECG out cables from service and destroy them, documenting such action on the attached reply form, which should be returned to Philips. Customers should retain a copy of the reply form. The customer should follow the Instructions for Use that describe the recommended approach for performing cardioversion with the XL+ and MRx monitor/defibrillators. The ECG trunk cable can be disconnected from the Philips bedside monitor and connected to the monitor/defibrillator before delivering therapy; this is the preferred source of an ECG waveform for synchronization.


  • Modelo / Serial
    M1783A/M5526A 12-pin Sync cables  All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    1067 US customers 163 Canada, 917 International
  • Descripción del producto
    ECG Out Cable - Heartstart MRx || M1783A/M5526A 12-pin Sync cables || All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. || Manufactured - September 4, 2002 October 8, 2014
  • Manufacturer


  • Dirección del fabricante
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
  • Source