The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge field service engineer (fse) evaluated the iabp unit and was able to confirm the reported issue in the fault logs.The fse found the drive manifold leaking, and the scroll compressor was due for rebuild.To fix the issue, the fse replaced the drive manifold and completed a 5000 hour rebuild of the scroll compressor.The fse performed full functional, calibration, and safety checks.The unit passed all tests to meet factory specifications however, due to the intermittent' s of the reported issue, the fse and the customer agreed that the iabp should be burned in with a iab (intra-aortic balloon) and a system trainer.The fse followed up with the customer and confirmed that the unit has been operating without incident.The iabp was returned to customer and cleared for clinical use.
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