Events

Retiro De Equipo (Recall) de Device Recall Maquet Datascope, Corp. Inc.

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 Maquet Datascope Corp - Cardiac Assist Division.

¿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
    69863
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1062-2015
  • Fecha de inicio del evento
    2014-12-16
  • Fecha de publicación del evento
    2015-02-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131722
  • 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
    System, balloon, intra-aortic and control - Product Code DSP
  • Causa
    Ferrule cap was not removed on some fiber-optic sensation and sensation plus iabc demonstration units. if fiber-optic connector is inserted into the maquet cs300 or cardiosave iabp, cap will prevent connection of unit and may become dislodged and remain in iabps fiber-optic receptacle.
  • Acción
    Maquet Inc. sent a Product Recall Medical Device Field Correction letter/Field Correction response form, dated 12/16/2014 via Fed Ex. The letter identified the affected product and the reason for the recall. Users were asked to inspect their inventory for the affected units. If customers have any affected product, they are to follow the instructions provided. Additionally, users are to complete and return the attached Field Correction Response Form to acknowledge receipt of the letter and to indicate completion of the steps outlined. Completed forms should be returned by e-mailing a scanned copy to fieldactions@maquet.com or faxing a copy to 1-973-396-3607. Technical questions should be directed to the Technical Support Department at 1-800-777-4222.

Device

Device Recall Maquet Datascope, Corp. Inc.
  • Modelo / Serial
    Sensation 7 fr.34 cc IAB Demonstration Unit  0684-DC-0433 0684-DO-0433 0684-DC-0469 0684-DO-0469  Sensation 7 Fr. 40 cc IAB Demonstration Unit 0684-DC-0434 0684-DO-0434 0684-DC-0470 0684-DO-0470  Sesnsation Plus 7.5 Fr. 40cc IAB Demonstration Units  0684-DC-0567 0684-DO-0567 0684-DC-0568 0684-DO-0568  Sensation Plus 7.5 Fr. 50cc IAB Demonstration Units 0684-DC-0575 0684-DO-0575 0684-DC-0576 0684-DO-0576  Sensation Plus 8 Fr. 50 cc IAB Demonstration Unit 0684-DC-0272 0684-DO-0272
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx || An electromechanical system used to inflate and deflate intra-aortic balloons.
  • Manufacturer
    Maquet Datascope Corp - Cardiac Assist Division

Manufacturer

Maquet Datascope Corp - Cardiac Assist Division
  • Dirección del fabricante
    Maquet Datascope Corp - Cardiac Assist Division, 1300 MacArthur Blvd., Mahwah NJ 07430-2052
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA