Device Recall Task Force Monitor 3040

  • Modelo / Serial
    Serial numbers: 003040i-2014-161-014-GG-0000, 003040i-2015-101-003-GG-0000, 003040i-2014-161-001-GG-0000, 003040i-2014-161-002-GG-0000, 003040i-2014-161-003-GG-0000, 003040i-2014-161-004-GG-0000, 003040i-2014-161-005-GG-0000, 003040i-2014-161-006-GG-0000, 003040i-2014-161-007-GG-0000, 003040i-2014-161-008-GG-0000, 003040i-2014-161-009-GG-0000, 003040i-2014-161-010-GG-0000, 003040i-2014-161-011-GG-0000, 003040i-2014-161-012-GG-0000, 003040i-2014-161-013-GG-0000, 003040i-2014-161-015-GG-0000, 003040i-2014-161-016-GG-0000, 003040i-2014-161-017-GG-0000, 003040i-2014-161-018-GG-0000, 003040i-2014-161-019-GG-0000, 003040i-2014-161-020-GG-0000, 003040i-2014-161-021-GG-0000, 003040i-2014-161-022-GG-0000, 003040i-2014-161-023-GG-0000, 003040i-2014-161-024-GG-0000, 003040i-2014-161-025-GG-0000, 003040i-2015-101-001-GG-0000, and 003040i-2015-101-002-GG-0000
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including MI and CA.
  • Descripción del producto
    CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (contBP). Furthermore Sympathic Tone and Parasympathic Tone are calculated by power spectral analysis of ECG (heart rate variability) and continuous blood pressure (blood pressure variability) as well as the Baroreceptor Reflex Sensitivity (BRRS). For use by medically trained personnel. It has been designed for diagnoses aiding and must not be used for vital sign monitoring of critically ill patients under absence of additional, suitable self-monitoring devices or medical trained personnel. The device measures continuously the subject's hemodynamic parameters without reporting any diagnosis. It is the physician's responsibility to make proper judgment based on these parameters.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Partners In Medicine Llc, 11469 Olive Blvd Ste 127, Saint Louis MO 63141-7108
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA