The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date.While the getinge field service engineer (fse) was performing the pm on this iabp unit and another, he exchanged the pneumatic module from the other unit to this unit to test.When doing so, it damaged the power management board.The fse ordered and replaced the power management exchange board.The fse then completed the diagnostic and performance tests on the iabp unit with no issues.He then completed the pm with full calibration, functional testing and safety check to factory specifications.The unit was released for clinical use and returned to the customer.
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While completing the scheduled preventative maintenance (pm) on the intra-aortic balloon pump (iabp), the company representative tried a part that was questionable from another unit to troubleshoot it.The part caused the solenoid control board to blow a component.There was no patient involved, thus no adverse event was reported.
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