Events

Retiro De Equipo (Recall) de Device Recall ReviveR AED semiautomatic external defibrillator used with the DBP2800 Battery Pack

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
    55497
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1782-2010
  • Fecha de inicio del evento
    2010-05-21
  • Fecha de publicación del evento
    2010-06-10
  • 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=90995
  • 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 aed when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy.
  • Acción
    Defibtech, LLC issued an "Urgent Medical Device Safety Information and Correction" notification dated May 20, 2010 by email and hard copy via US Mail. The notification instructed Consignees on proper identification of affected product and steps to take for product replacement. For further information, contact your distributor or Defibtech Technical Support at techsupport@defibtech.com or call 1-877-453-4507 or 1-203-453-4507, 8:30 AM to 5:00 PM Monday - Friday, EST.

Device

Device Recall ReviveR AED semiautomatic external defibrillator used with the DBP2800 Battery Pack
  • Modelo / Serial
    Serial Numbers range from 202001005 through 202005916 and 206001001 through 206009871.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland.
  • Descripción del producto
    ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483. || The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.
  • Manufacturer
    Defibtech LLC

Manufacturer

Defibtech LLC
  • Dirección del fabricante
    Defibtech LLC, 4 Progress Ave, Seymour CT 06483-3921
  • Empresa matriz del fabricante (2017)
    Nihon Kohden Corp.
  • Source
    USFDA