The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the 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 evaluate this unit and was able to reproduce the reported issue.The fse found ¿autofill failure", codes 57 & 62 in the fault logs.The fse reported that the system vacuum was below specifications.The fse inspected all the hoses and connections and installed the 5000-hr rebuild kit including heads to resolve the problem.The system vacuum is now meets the specifications.The fse then perform all functional, pneumatic and electrical safety tests as per factory specifications.The unit passed all tests performed and was returned to the customer and cleared for clinical use.
|