Manufacturer statement: for evaluation of the malfunction dhr documents were reviewed.They demonstrate that the catheter neurovent-p (sn (b)(4)) met specification during manufacturing.Final inspection of the finished catheter was passed.This demonstrates that the catheter has been manufactured and sold in conformance to relevant specifications.Furthermore returned catheter was investigated.This investigation demonstrates that one wire is torn apart from the soldering pads on the pcb.Based on knowledge that the final inspection of the finished catheter was passed, that the catheter was delivered with proper functionality and in consideration of the results of performed investigation of returned catheter, the tear-off of the wire is caused by user error by stretching of the catheter during application contrary to ifu.
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