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 the customer's site.The fse evaluated the iabp and could not duplicate the alleged malfunction.However, the fse found saline on the motor control board and replaced the motor control board and executive processor board as a precautionary measure.A ffll functional verification was performed and the iabp passed and was returned to the customer for clinical use.
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