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) was dispatched to evaluate the iabp unit and was able to reproduce the reported issue.The fse determined that the executive processor board was the issue.To fix the issue, the fse replaced the executive processor board.The fse received a power up alarm and to address this issue, the fse had to calibrate the transducer.The fse performed all calibration, functional and safety checks to meet and pass factory specifications.The unit was released to the customer and cleared for clinical service.
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