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 observed the slow start up of the iabp.To resolve the issue, the fse reinstalled the software and cleaned the coiled cord connection.The fse then performed a full calibration and functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.
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