Updated fields: a3, b4, e1 (event site email), g4, g7, h2, h10, h11.Corrected fields: b5, d5, h3, h6 (type of investigation, health effect - impact codes).Testing of actual/suspected device (10): a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and observed within the iabp log files that the end user had experienced the reported issue on (b)(6) 2021 and continued to use the iabp unit until (b)(6) 2021.The fse tested the iabp unit per factory specifications and was unable to duplicate the reported issue.The iabp unit was then ran on a system trainer for 30 minutes and no alarm was encountered.Subsequently, the fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.
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