One clearsight pump unit was received for product evaluation.The examination found that the battery capacity was 0.The battery was charged overnight before testing.The suspect pump unit was tested using a known good working clearsight system and it passed the test.The ft4 calibration test was performed and it passed the test.The product performed normally.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.Issues such as poor finger perfusion, improperly applied finger cuff, incorrectly sized finger cuff, improper application of the hrs or failing to zero the hrs sensor may lead to inaccurate hemodynamic measurements.The operators manual instructs the use on these above stated factors that can lead to inaccurate values.The device history record review was completed and all manufacturing inspections passed with no non conformances.The reported event was not confirmed by evaluation.There was no indication or evidence of a manufacturing defect being responsible for the issues.It could not be determined if any clinical or procedural factors may have contributed to the event.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 the monthly review.No further actions will be taken at this time.
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