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.A getinge field service engineer (fse) was dispatched and could not duplicate the reported malfunction.No error codes were present from the day that the malfunction occurred.The fse performed a full preventive maintenance (pm) on the device, including pressure and leak tests that could indicate the cause of the reported alarm.The iabp passed all calibrations and functional tests in accordance with the iabp's respective service manual.The iabp was then returned to the customer and cleared for clinical use.
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