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) indicated that the voltage between tp 5 and 4 were our of range, the stm could not achieve proper voltage by changing the dip switch configuration.To address the issue the stm replaced the solenoid driver board.The stm installed 2.5k pm kit as a part of pm.The stm then performed pm, all functional and safety tests which passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.(b)(6).
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