Investigation: visual inspection.During the investigation, a deformation of the outer housing of the prosa could be determined.The measurement of the plane parallelism could confirm that with a value of -0.088 mm - outside tolerance (0 0.02 mm).Permeability test.A permeability test has shown that the valve is permeable.Computer controlled test.To investigate the flow rate, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.The results show that the prosa operates within the accepted tolerance in either position.Adjustment test.The prosa 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.Internal inspection.After dismantling of the valve, deposits were found in the prosa.Results.Based on our investigation results, we can determine deposits and a deformation.The deposits and the deformation had no affect to the technical properties at the time of the investigation.The cause of the aforementioned functional impairment is not known to us at the time of the examination.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.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.No further regulatory actions are required from our point of view.
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