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 field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and confirmed an intermittent issue.The fse checked the electrical faults and observed power-up fault 13 and error codes 111,112, and 115; all codes allude to faults with the executive processor board and front end board.The fse replaced the front end board and the issue still persisted.The fse noted that the executive processor board was just replaced two months ago.The fse ordered the new boards to be installed and later returned to the customer¿s site for repair.Upon return, the fse was able to see what the unit was doing at start-up; spinning shell on display and alarm after 2 minutes and shutdown numerous times.The unit was finally able to boot-up in maintenance menu.The fse checked the electrical fault codes and still noted code 13 occurred.After checking the error codes, the fse observed 78, 101, 111,112 and 115; code 101 referred to issue with the power management board.The fse replaced the power management board; other codes point to a communication issue between the display and the console.The fse tried a different display and coiled cord and still the issue remained; thus eliminated the video generator board.The fse disassembled the complete unit and top cover and installed a new internal display cable to back plane board, reassembled and unit now starts up as it should.The fse then restarted the unit 10 times and all came up as it should.The fse ran a complete calibration and functionality tests and all passed.The iabp unit ran on the trainer and test balloon for approximately one hour and all works as it should at this time.The iabp unit was cleared for use.
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