Events

Retiro De Equipo (Recall) de Device Recall eCareManager

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 Visicu, 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
    70931
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0399-2016
  • Fecha de inicio del evento
    2015-03-27
  • Fecha de publicación del evento
    2015-12-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-09-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135619
  • 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
    System,network and communication,physiological monitors - Product Code MSX
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    eCareManager v3.7, 3.7.1, v3.8, and v3.9
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US distribution only.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Visicu, Inc., 217 E Redwood St Ste 1900, Baltimore MD 21202-3315
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA