Events

Rappel de Device Recall Capsule Neuron UMPC

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Capsule Tech Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    58636
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2403-2011
  • Date de mise en oeuvre de l'événement
    2010-08-25
  • Date de publication de l'événement
    2011-06-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99753
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Monitor, physiological, patient (with arrhythmia detection or alarms - Product Code MWI
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Serial Numbers: TS9800281 - TS9801370 TS9900645 - TS9900654 TS9B00103 - TS9B01109 TSA300737 - TSA301336 TSA600927 - TSA601526 TSA800623 - TSA801221 TSAA00335 - TSAA00338 TSAB01605 - TSAB02204 TSB300957 - TSB301460
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the country of Canada
  • Description du dispositif
    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.
  • Adresse du fabricant
    Capsule Tech Inc., 300 Brickstone Sq, Andover MA 01810-1492
  • Source
    USFDA