CNSystems TASK FORCE MONITOR 3040i…

Date

Jan. 13, 2016

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Partners In Medicine Llc

Product

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.

Reason

Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation of systolic blood pressure, underestimation of diastolic blood pressure).

Distribution pattern

Nationwide Distribution including MI and CA.

Quantity

28 worldwide 2 monitors distributed in the U.S.

Codes and lots

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

Recall started

Dec. 1, 2015

Device type

Plethysmograph, Impedance

Root cause (FDA)

Mixed-up of materials/components

What the company told customers

CNSystems sent an Urgent Medical Device Recall Safety Notice dated December 1, 2015, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. CNSystems decided to perform a voluntary recall of the affected devices and to return the devices after repair (free of charge). For questions regarding this recall call 314-324-2470.

Recall number

Z-0572-2016

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0572-2016. The agency record governs; check it and the company before acting.