It was reported that during use with patient, this disposable pressure transducer, provided inaccurate values.There is no further information available at this time.There was no allegation of patient injury.The product was available for evaluation.Patient demographics are not available.
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One single dpt kit was received for evaluation.The reported event of inaccurate values was not confirmed.The dpt zeroed and sensed pressure accurately on the pressure monitor.Pressure did not drift during output drift test and met specification.Electrical testing showed that both input impedance and output impedance were within specifications.Zero-offset value also met specifications.No leakage or occlusion was detected from the kit during pressure test.No visible damage was observed from the kit.A device history record review was completed and documented that device met all specifications upon distribution.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 not known if user or procedural factors may have 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.No corrective or preventative actions are required at this time.
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