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.The getinge service territory manager (stm) reinstalled the membranes and gaskets on compressor assembly.Ran pressure performance tests with satisfactory results.The iabp passed all calibration, functional and safety tests per factory specifications.The iabp was returned to the customer and cleared for clinical use.
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