Visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Permeability test: a permeability test has shown that the m.Blue is not permeable.Computer controlled test: measurement on the computer test bench was not possible due to the occlusion.Adjustment test: the m.Blue 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 inside results: based on our investigation results, we can determine a non-adjustability and a blockage in the valve.The determined deposits can be named as the cause for the functional deviation.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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