The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated and noted that there was an artifact on the screen.The stm cleaned and reseated the video driver cable which corrected the display issue.Subsequently, the stm 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.The full name of the event site was shortened due to field character limit; the full name is (b)(4).
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