The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.It was reported that a getinge field service engineer (fse) performed running tests in the getinge (b)(4) office.The reported incident was not duplicated, however, the fse changed the solenoid driver board.The fse then performed the running test a second time and no other issues occurred.The iabp was returned to the customer cleared for clinical use.
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The customer reported that while the cs300 intra-aortic balloon pump (iabp) was in use on a patient, the iabp unexpectedly shutdown.The customer made an attempt to restart and iabp and was able to restart it once, however, the iabp shutdown again.This iabp has recently had its solenoid driver board replaced as part of a field safety corrective action (fsca).The customer swapped out the iabp to continue therapy.No adverse event has been reported.
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