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 service territory manager (stm) evaluated the iabp and confirmed the problem as stated by the customer.The stm disassembled the monitor, removed and replaced the damaged lcd screen and reassembled and performed all functional and calibration verification.The iabp passed all functional and safety tests and is now ready for clinical use.
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