Events

Retiro De Equipo (Recall) de Device Recall Capsule Neuron UMPC

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 Capsule Tech 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
    58636
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2403-2011
  • Fecha de inicio del evento
    2010-08-25
  • Fecha de publicación del evento
    2011-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99753
  • 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
    Monitor, physiological, patient (with arrhythmia detection or alarms - Product Code MWI
  • Causa
    Software: data cached on the neuron due to server unavailability is not being delivered to the server after server availability is restored. if a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes. batteries can discharge completely in a capsule neuron" umpc even though it is connected to power source.
  • Acción
    Capsule Tech initiated three corrective action notifications for the Neuron" UMPC units three failure modes as follows: a) Data cached on the Capsule Neuron" UMPC due to server unavailability is not being delivered to the server after server availability is restored: i) A customer advisory was provided to a subset of consignees, along with DataCaptor software version 6.6.5 on December 1, 2010. ii) A customer advisory was provided to the remaining consignees, along with DataCaptor software version 6.6.7 on January 27, 2011. If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes: i) A customer advisory was provided to all consignees on March 23, 2011, via phone call, email and FedEx;.The correction will be provided as a software update. A formal recall notification letter will be provided to all consignees alerting them to the availability of the correction once it is released, via phone call, email and FedEx. c) Batteries can discharge completely in a Capsule Neuron" UMPC even though it is connected to power. Note: the Capsule Neuron" UMPC operates normally when connected to power. i) A customer advisory was provided to all consignees on April 23, 2010, via FedEx. For questions regarding this recall contact Capsule technical support team at (800) 260-9537 or e-mail support@capsuletech.com..

Device

Device Recall Capsule Neuron UMPC
  • Modelo / Serial
    Serial Numbers: TS9800281 - TS9801370 TS9900645 - TS9900654 TS9B00103 - TS9B01109 TSA300737 - TSA301336 TSA600927 - TSA601526 TSA800623 - TSA801221 TSAA00335 - TSAA00338 TSAB01605 - TSAB02204 TSB300957 - TSB301460
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the country of Canada
  • Descripción del producto
    Capsule Neuron UMPC is a component in the DataCaptor" Connectivity System. || Catalog Number: DC-NU-MPC || Capsule Neuron" UMPC is a bedside device that enables automatic collection of vital signs data that can local cache data and connect to the hospital network through a wired || Ethernet connection or via a standard 802.11 b/g/n wireless network, available in a fixed or mobile mounting option, running either DataCaptor continuous or periodic connectivity software || The DataCaptor" System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor" is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to
  • Manufacturer
    Capsule Tech Inc.

Manufacturer

Capsule Tech Inc.
  • Dirección del fabricante
    Capsule Tech Inc., 300 Brickstone Sq, Andover MA 01810-1492
  • Source
    USFDA