Visual inspection: no anomalies were detected on the progav 2.0 valve during the visual inspection permeability test: a permeability test has shown that the progav 2.0 is permeable.Computer controlled test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in the horizontal positions.The results show that the progav 2.0 operates within the accepted tolerance in the horizontal position.Adjustment test: the progav 2.0 valve was tested and is not adjustable throughout the normal range.Braking force and brake function test: the brake functionality test has shown that the brake function is operational; however, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valve, deposits were found in the progav 2.0 results: based on our investigation results, we can determine that the valve is not adjustable.The visible deposits found in the valve may have led to the functional impairment.Deposits caused by natural substances in the body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Ven small amounts of proteins can impair the integrity of the valve.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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