Events

Retiro De Equipo (Recall) de Device Recall HeartStart MRx Monitor/Defibrillator

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
    Recall
  • ID del evento
    79982
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2035-2018
  • Fecha de inicio del evento
    2018-05-03
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164128
  • 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
    The mrx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. failure to charge could potentially cause therapy to be interrupted or delayed.
  • Acción
    On May 3, 2018, the firm issued an Urgent Amended Medical Device Correction notice to affected customers via certified mail. Customers were reminded that they were previously notified in April 2016 regarding the same issue. At that time, the firm committed to providing a replacement for all affected MRx units. The May 2018 notification was sent only to remaining customers who had not yet received a replacement device. Those customers were informed that due to the product being discontinued, their affected units would receive a replacement therapy board instead of a replacement unit. Customers were informed that they could continue to use their MRx prior to repair. But, if they observe a red X in the Ready for Use indicator, to follow the troubleshooting instructions in the MRx IFU. They were also advised that they would be contacted by Philips to schedule the repair of the device. If the customer has already returned their unit but has not yet received a replacement, they were advised that Philips will be replacing the therapy board, not the entire device. If you need further information or support concerning this notification, please contact your local Philips representative or call the firm at 1-800-722- 9377.

Device

Device Recall HeartStart MRx Monitor/Defibrillator
  • Modelo / Serial
    US00588464, US00588657, US00589878, US00591080, US00593861
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.
  • Descripción del producto
    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) || Product Automated external defibrillators (non-wearable) || Product Usage: || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

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