Manufacturing and quality control date: the progav 2.0 shunt system was manufactured by a qualified employee in december 2017.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.Investigation: visual inspection: scratches and bloody residue on the outer casing of the valve were observed through the visual inspection.No other significant deformations or damages were detected.Permeability test: the test has indicated that the valve has a blockage.Adjustment test: the valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Results: first we performed a visual inspection of the progav 2.0 valve.Scratches and bloody residue on the outer casing of the valve were observed through the visual inspection.No other significant deformations or damages were detected.Then we tested the permeability of the valve, as well as the brake functionality and braking force.The valve operated as expected and met all specifications.Finally, we have dismantled the valve.Inside the valve we have found a slight build-up of substances (likely protein), which may have caused the suspected malfunction in the past.Based on our investigation, we are unable to substantiate the claim of non-adjustability.The valve operates within the specified tolerances.However, it is possible that the deposits observed inside the valve could have caused the malfunction in the past.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.
|