Events

Retiro De Equipo (Recall) de Device Recall Sentry semi automatic external defibrillator (AED)

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 Defibtech, LLC.

¿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
    56729
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0077-2011
  • Fecha de inicio del evento
    2010-08-27
  • Fecha de publicación del evento
    2010-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94386
  • 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
    Data cards may include an incorrect format which may cause the aed to not function correctly.
  • Acción
    Defibtech Initially notified customers by telephone on 8/27/10. Customers were notified of the product, the problem and the action to be taken. Customers were instructed to locate affected data cards and send them back to Defibtech for evaluation. If the data card was inserted into the AED, then the customer was instructed to check the AED software version. If the software version was at 2.005, the customer was instructed to keep the AED out of service until Defibtech could evaluate the returned data card. (Any other software version indicated that the device was not affected by a faulty data card). If the software version was any other version other than 2.005, then the customer was instructed to keep the AED in service unless the original service inquiry required it to remain out of service. If the data card was not inserted into the AED, then the customer was instructed to return the data card for evaluation. For any questions customers were to contact Customer Service at (866) 333-4241 from 8:30-5pm EST, M-F.

Device

Device Recall Sentry semi automatic external defibrillator (AED)
  • Modelo / Serial
    Data cards are not serialized. Data cards are traced by shipment dates from July 19, 2010 through August 25, 2010.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    USA - Nationwide Distribution and Puerto Rico
  • Descripción del producto
    DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). || The DDC-6-AA data card is an accessory to the AED and does not have its own intended use.
  • Manufacturer
    Defibtech, LLC

Manufacturer

Defibtech, LLC
  • Dirección del fabricante
    Defibtech, LLC, 741 Boston Post Rd Ste 201, Guilford CT 06437-2714
  • Source
    USFDA