The complaint component was returned and analyzed, and the reported allegations of inflation issue and mechanical issue were confirmed via product analysis.The ambicor cylinders, pump and tubing were visually inspected.Both cylinders had leak in proximal cylinder body that was the result of sharp instrument damage consistent with explant damage; hole was present.Due to this damage being consistent with explant it will be considered a secondary failure.Both cylinders had broken fabric treads in cylinder body attributed to fatigue and wear at fold.The kink resistance tubing (krt) was fatigue and worn to the filament; no leak was found.No damage was identified in relation to the pump.However, product analysis concluded that identified broken fabric treads in the cylinder was the most probable cause of the reported events.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure.Based on the results of this investigation, no escalation is required.
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