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) evaluated the iabp and confirmed the problem stated by the customer, unit was leaking 45psi of the 65psi allowable tolerance.Troubleshot the unit per service manual and found the leak to be in cart and not in the console.Fse started by replacing the gasket on the helium cylinder, found the leak was persistent, replaced the high pressure regulator, high pressure transducer o-ring, and quick disconnect o-ring, lubed all connections with vacuum grease, reassembled the unit and ran leak test.Leak test passed with a tolerable pressure of 2 psi out of 65 psi allowable pressure.Fse reassembled the unit and completed all functional test and calibrations, unit has passed all test and is now ready for clinical use.
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