The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit but was unable to duplicate the customer's reported issue, and did not observe any issues logged in the iabp log files.The stm ran the fiber optic tests multiple times, and the unit passed all calibration, functional and safety tests to factory specifications.The iabp unit was released to the customer and cleared for clinical use.
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