Events

Rappel de Device Recall eCareManager

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
    70931
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0399-2016
  • Date de mise en oeuvre de l'événement
    2015-03-27
  • Date de publication de l'événement
    2015-12-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-09-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135619
  • 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
    A software defect may cause incorrect medication order change. if the user decides to edit the order prior to electronic signature and selects the return to previous screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. at the stage where the order is signed, the medication displayed may be incorrect.
  • Action
    Philips Visicu sent an "Field Safety Notification" to all affected customers still using an affected version of eCareManager. (4 Customers) 03/27/2015 The letter identified the problem and circumstances in which the defect can occur; recommend actions the customer should take to prevent risks for patients; and list the actions planned by Philips to correct the problem. "Philips Hospital to Home has taken corrective action to address the software defect in all supported versions of eCareManager software. Philips Hospital to Home is working with affected customers to complete the necessary upgrade. Please contact your local Philips Representative for further questions.

Device

Device Recall eCareManager
  • Modèle / numéro de série
    eCareManager v3.7, 3.7.1, v3.8, and v3.9
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US distribution only.
  • Description du dispositif
    The eCareManager system. Software 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. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.
  • 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