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 the iabp unit and observed the customer's reported issue and noted there was no autofill operation.The stm tested the iabp unit in diagnostics and observed the k7 solenoid on the drive manifold assembly was inoperative and not activating the vacuum side of the compressor.The stm troubleshot the k7 solenoid and removed and replaced the drive manifold assembly which corrected the reported 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.(b)(6).
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