Events

Retiro De Equipo (Recall) de Device Recall Centricity Perinatal (formerly QS) System PFILS software

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 GE Healthcare Integrated IT Solutions.

¿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
    48755
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2037-2008
  • Fecha de inicio del evento
    2008-06-30
  • Fecha de publicación del evento
    2008-07-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72063
  • 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
    perinatal patient monitoring system - Product Code HGM
  • Causa
    Patient information mix-up: when the pfils application, configured with a backup server has experienced a network interruption, pfils verify could result in the centricity perinatal application recording non-identifiable patient information to the incorrect patient file.
  • Acción
    GE Healthcare notified their Centricity Perinatal customers via letter dated 7/20/07 of the problem with the PFILS application that could result in the Centricity Perinatal application recording non-identifiable patient information to the incorrect patient file. The letter provided the users with a workaround and provided them with a Frequently Asked Questions document which listed the availability of a software patch to fix the problem. A follow-up letter dated 6/27/08 was sent on 6/30-7/2/08 to those accounts who had not requested a PFILS Hotfix CD-ROM or had not had their software recently upgraded. The letter a copy of the 7/20/07 letter, the most recent FAQ, the PFILS Hotfix CD (PFIL67_66) and Installation Procedure for the PFILS Patch instructions for installation of the software patch. The accounts were advised that they can request an analysis of existing patient records to determine whether they have been affected by the PFILS issue, by submitting a non-critical Technical Support Request on the GE Centricity Perinatal Web site: http://www.gehealthcare.com/usen/security/cis/stupgrades.html, indicating "PFILS ANALYSIS REQUEST" in the Description of Issue field. Any questions were directed to Technical Support at 800-433-2009.

Device

Device Recall Centricity Perinatal (formerly QS) System PFILS software
  • Modelo / Serial
    All CPN versions up to 6.70.6 P02 with PFILS versions below 2.0
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide: USA, Puerto Rico, Canada, and China.
  • Descripción del producto
    GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit.
  • Manufacturer
    GE Healthcare Integrated IT Solutions

Manufacturer

GE Healthcare Integrated IT Solutions
  • Dirección del fabricante
    GE Healthcare Integrated IT Solutions, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Source
    USFDA