Testing of actual/suspected device (10/213): a getinge field service engineer (fse) evaluated the iabp, but was unable to reproduce the reported "gas loss in iab circuit" issue.The fse ran the iabp unit at 80, 100, and 130 beats per minute (bpm) without issue.He then 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 to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.The full event site name is (b)(6).
|