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.The getinge stm was unable to adjust the voltage readings and found the issue to be with the solenoid driver board.The stm replace the solenoid drive board to correct the issue, then completed pm service including all safety, functionality, and calibration checks.All tests passed to factory specifications and the iabp unit was cleared for clinical use and released to the customer.(b)(6).
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