Investigation visual inspection a deformation of the outer housing of the prosa valve was observed through the visual inspection.The prosa valve housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at -0.0495 mm, outside the tolerance of 0 ± 0.02 mm.Permeability test a permeability test has shown that the prosa valve is permeable.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.Results it should be noted that the prosa valve was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.First, we performed a visual inspection of the prosa valve.A deformation of the outer housing of the prosa valve was observed through the visual inspection.This deformation was confirmed through a measurement of the plan parallelity.Next, we tested the permeability and adjustability, as well as the brake functionality and brake force.The prosa valve operates as expected and met all specifications.Finally, we have dismantled the valve.Inside the valve we have found slightly build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of non-adjustability.At the time of our investigation, the prosa was able to be adjusted to all specified settings.How it came to the mentioned functional impairment is not revealed to us at the time of the investigation.We suspect that the detected deformation could be responsible for the functional impairment of the adjustability.Significant outside pressure, for example by too much force from the prosa adjustment tool or by a fall or impact to the head of the patient, can compromise 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.
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