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) was dispatched to the customer's site.The fse performed battery runtime test and received a result below getinge¿s specification before the iabp shutdown.The fse believed the batteries were not fully charged when customer experienced the problem.Due to the battery runtime being below getinge specification.The fse replaced the 2 batteries.The fse then performed all diagnostic, safety, and functional tests to factory specification.The iabp was returned to customer, and cleared for clinical use.The full name of the event site noted in block is (b)(6).
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