The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed 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 and was unable to duplicate the reported issue.However, the stm observed "auto-fill failure" errors in the system log file and found that the drive pressure regulator was drifting during the drive pressure calibration.The stm replaced the drive pressure regulator and then performed all calibration, functional and safety tests which passed per factory specification.The iabp was returned to the customer and cleared for clinical service.
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