Events

Retiro De Equipo (Recall) de Device Recall 8870 Software Application Card Version AAA 02

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 Medtronic Inc, Neurological & Spinal 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
    29849
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1334-04
  • Fecha de inicio del evento
    2004-08-24
  • Fecha de publicación del evento
    2004-09-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34649
  • 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
    Pump, Infusion, Implanted, Programmable - Product Code LKK
  • Causa
    With the model 8870 software application card versions aaa 02, bbb 04, bbc 02, and bbd 01, which is used in conjunction with the model 8840 n'vision clinician programmer, users may have mistakenly entered a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. this issue is limited to programming the synchromed and synchromed el pumps.
  • Acción
    Letters were distributed 8/24/2004 utilizing a courier with signed receipt upon delivery. The letters were signed for upon receipt at the consignee address, and the contents of the letter included a response form which can be faxed or mailed back to Medtronic. If any letters are returned as 'undeliverable', attempts will be made to telephone these consignees. A press release was issued on September 22, 2004 by Medtronic Inc. for all Version AAA 02 Model 8870 software application cards in the U.S.

Device

Device Recall 8870 Software Application Card Version AAA 02
  • Modelo / Serial
    Software Version AAA 02, BBB 04, BBC 02, and BBD 01
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    These cards were distributed primarily in the USA, but also to countries in Europe, Middle East and Africa, Canada, Australia, Hong Kong, Latin America and Japan.
  • Descripción del producto
    8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N''Vision Clinician Programmer.
  • Manufacturer
    Medtronic Inc, Neurological & Spinal Division

Manufacturer

Medtronic Inc, Neurological & Spinal Division
  • Dirección del fabricante
    Medtronic Inc, Neurological & Spinal Division, 800 53rd Ave Ne, Columbia Heights MN 55421-1241
  • Source
    USFDA