Testing of actual/suspected device: (10/213) a getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue of "fiber optic error", the issue was confirmed in the logs, and the iabp failed fiber optic function test.To fix the issue, the fse replaced the fiber optic sensor, and the fiber optic screw kit was consumed.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.(b)(6).
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