Events

Retiro De Equipo (Recall) de Device Recall Powerheart AED G3

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, Inc..

¿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
    30704
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0399-05
  • Fecha de inicio del evento
    2004-11-12
  • Fecha de publicación del evento
    2005-01-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-06-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36660
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    unknown device name - Product Code NPN
  • Causa
    Aeds may contain an electronic component that does not meet its full operating specifications. the aeds with this suspect electronic component may not functionn properly and may interfere with the aed's ability to delivery therapy. in the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.
  • Acción
    Cardiac Science will contact customers via telephone to set up a time for Clinical Educator to visit the customer and conduct a field test on each AED. AEDs that fail the field test will be replaced either on the spot or within 24 hours. AEDs failing the test are either removed by the Clinical Educator or are returned to Cardiac Science upon receiving the new AED. Cardiac Science anticipates testing to be done by the end of December 2004.

Device

Device Recall Powerheart AED G3
  • Modelo / Serial
    Model no. 9300A serial numbers: 361240 thru 361317, 362360 thru 362386, 362394, 362715 thru 362914, 364195 thru 364274, 364555 thru 364594, 364915 thru 365294.
  • Clasificación del producto
    Cardiovascular Devices
  • Distribución
    Throughout the United States, Canada and Europe.
  • Descripción del producto
    Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
  • Manufacturer
    Cardiac Science, Inc.

Manufacturer

Cardiac Science, Inc.
  • Dirección del fabricante
    Cardiac Science, Inc., 5474 Feltl Rd, Minnetonka MN 55343-7982
  • Source
    USFDA