Events

Retiro De Equipo (Recall) de CareSuite" Critical Care Manager, PACU Manager and Anesthesia Manager

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 Picis 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
    53897
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3277-2011
  • Fecha de inicio del evento
    2009-08-12
  • Fecha de publicación del evento
    2011-09-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86830
  • 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
    Software, transmission and storage, patient data - Product Code NSX
  • Causa
    Electronic health record software applications malfunctioned in a manner which failed to display the discontinued status for medication orders, as entered by the attending physician.
  • Acción
    Picis Inc. sent a customer notification letter dated August 11, 2009 to all affected customers. The letter describes the product, problem, and action to be taken. Customers informed of the potential patient safety error were advised to make the appropriate configuration change, within current software versions 7.1.4 or later. Contact your local Picis support representative for questions regarding this notice.

Device

CareSuite" Critical Care Manager, PACU Manager and Anesthesia Manager
  • Modelo / Serial
    S/W version 7.1 release date - February 2004
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Brussels, Belgium, Denmark, Finland, France, Germany, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and UK.
  • Descripción del producto
    CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software, transmission & storage, patient data. || This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.
  • Manufacturer
    Picis Inc.

Manufacturer

Picis Inc.
  • Dirección del fabricante
    Picis Inc., 100 Quannapowitt Parkway, Suite 405, Wakefield MA 01880
  • Empresa matriz del fabricante (2017)
    Constellation Software Inc
  • Source
    USFDA