One single dpt kit was returned for examination.The reported event of pressure reading issue was not confirmed.The dpt sensor zeroed and sensed pressure accurately on a pressure monitor.Pressure readings were stable during 8 hours of an output drift test.Electrical testing showed that both input and output impedances were within specifications.Zero-offset also met specification.No visible defect was observed from the kit.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.Poor dynamic response can be caused by air bubbles, clotting, and excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.The assembly may be tested for dynamic response by observing the pressure waveform on an oscilloscope or monitor.Bedside determination of the dynamic response of the catheter, monitor, kit and transducer system is done after the system is flushed, attached to the patient, zeroed and calibrated.A square-wave test may be performed by pulling the snap tab device and releasing quickly.Pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system.Pressure readings should correlate with the patient¿s clinical manifestations.It is unknown if user or procedural factors contributed to the stated event.In this event, there was no patient compromise noted.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
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