Investigation: visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Permeability test: a permeability test has shown that the valve is permeable.Computer control test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer control test bench which simulates a cerebrospinal fluid flow.The valve is tested in the horizontal position.The results show that the valve is not operating within the acceptable tolerance in the horizontal position.An accelerated outflow could be confirmed.Adjustment test: the progav 2.0 was tested and is not adjustable.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 progav 2.0.Result : based on our investigation results, we can determine an accelerated outflow and adjustment difficulties.The determined deposits can be named as the cause for the functional deviations.Organic materila 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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