Events

Retiro De Equipo (Recall) de GE Responder 2000 Defibrillator/Monitor

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 Cardiac Science 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
    55977
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0589-2011
  • Fecha de inicio del evento
    2010-04-28
  • Fecha de publicación del evento
    2010-12-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92350
  • 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
    Some units may be non-operational during a rescue, due to a defective pcb interconnect on traces connected to the reed relay. this will result in an inability to analyze the patient's heart rhythm or deliver therapy during a rescue.
  • Acción
    Cardiac Science issued a Urgent Medical Device Corrective Action letter dated April 28, 2010 requesting GE Healthcare cease distribution of affected devices and to instruct end users of distributed devices to schedule a service call to have the device corrected. Cardiac will send rework kits no later than June 30, 2010. CSC can be contacted at 44 161 926 0011 to arrange return material authorization and replacement of affected devices.

Device

GE Responder 2000 Defibrillator/Monitor
  • Modelo / Serial
    Serial Numbers:  3201281, 3201806, 3201810, 3201815, 3202223, 3202233, 3202244, 3202248, 3202249, 3202253, 3202255, 3202256, 3202257, 3202260, 3202262, 3202269, 3202271, 3202273, 3202275, 3202280, 3202281, 3202283, 3202284, 3202285, 3202286, 3202287, 3202288, 3202290, 3202291, 3202292, 3202297, 3202299, 3202300, 3202301, 3202303, 3202304, 3202305, 3202306, 3202308, 3202310, 3202311, 3202312, 3202313, 3202315, 3202316, 3202317, 3202319, 3202321, 3202324, 3202327, 3202328, 3202331, 3202332, 3202333, 3202334, 3202336, 3202337, 3202338, 3202339, 3202340, 3202344, 3202347, 3202348, 3202349, 3202350, 3202351, 3202352, 3202354, 3202355, 3202356, 3202357, 3202358, 3202360, 3202361, 3202362, 3202363, 3202364, 3202365, 3202371, 3202377, 3202379, 3202380, 3202381, 3202382, 3202385, 3202386, 3202387, 3202388, 3202389, 3202390, 3202391, 3202392, 3202393, 3202394, 3202395, 3202396, 3202397, 3202398, 3202399, 3202400, 3202401, 3202403, 3202404, 3202405, 3202406, 3202407, 3202408, 3202409, 3202411, 3202412, 3202414, 3202415, 3202416, 3202417, 3202418, 3202419, 3202420, 3202421, 3202422, 3202423, 3202427, 3202429, 3202439, 3202442, 3202443, 3202444, 3202447, 3202448, 3202450, and 3202451.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: Throughout the US, and in the countries of Germany, Korea, Peru, Singapore, and Spain.
  • Descripción del producto
    GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were manufactured between July 25, 2008 and October 2, 2009 by GE Healthcare.
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • Dirección del fabricante
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Empresa matriz del fabricante (2017)
    Cardiac Science Corporation
  • Source
    USFDA