(b)(6).Testing of actual/suspected device: the getinge field service engineer (fse) that encountered the issue found error codes 111,112,115 in logs and replaced the coiled cable cord and completed the pm with full calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, 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 if this information is provided to us.
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