The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.The field service engineer (fse) that discovered the unit to have failed the run time test, replaced the batteries.The iabp was calibrated and passed all functional and safety tests per factory specifications.The unit was returned to customer and cleared for clinical use.The initial reporter named is a getinge employee who has different contact details from that of the event site; his contact information are as follows: (b)(6).The first name of the initial reporter in block has been abbreviated due to field character limit; the full name should read: (b)(6).
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