Updated fields - e1(site country) ,h6(type of investigation, investigation findings, component code, investigation conclusions).A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue, the fse replaced drive manifold assembly and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released for cleared for clinical service.
|