The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.The getinge field service engineer (fse) that encounter the issue tried reseating the safety disk and the pim, and lubricating the safety disk connection points.However, that did not fix the issue.The fse replaced the safety disk and all manifold test passed.The fse then performed pm, all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.(b)(6).
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