Events

Rappel de Device Recall Philips eCareManager System

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 Visicu, 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
    61328
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1474-2012
  • Date de mise en oeuvre de l'événement
    2012-02-22
  • Date de publication de l'événement
    2012-04-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107808
  • 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
    System,network and communication,physiological monitors - Product Code MSX
  • Cause
    Three versions of software for the ecaremanager failed to display anticoagulants on the medications screen. the problem arose due to an unexpected change in the national drug data file.
  • Action
    Philips notified all affected customers via a preliminary email message advising them of the issue. An URGENT - Field Safety Notice follow-up letter was mailed to all customers on February 22, 2012. This letter identified the affected product, described the problem and circumstances in which it can occur; recommend actions the customer should take to prevent risks for patients, and list the actions planned by Philips to correct the problem. For questions contact Philips eICU Customer Support 877-374-2872.

Device

Device Recall Philips eCareManager System
  • Modèle / numéro de série
    v3.7, v3.7.1, v3.8
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution (USA) including states of MA, MO, WI, AR, AZ, PA, SD, VA, and IN.
  • Description du dispositif
    Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. || Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinical information management with independent bedside devices and ancillary systems that are connected either directly or through networks. The eCareManager system provides patient information and surveillance of monitored patients at the point of care location and at a remote, supplementary care location through wide area networking technology and dedicated phone lines and is solely intended for use in a hospital environment. It is not intended to be used in a home environment.
  • Manufacturer
    Visicu, Inc.

Manufacturer

Visicu, Inc.
  • Adresse du fabricant
    Visicu, Inc., 217 E Redwood St Ste 1900, Baltimore MD 21202-3315
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA