The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.The getinge service territory manager (stm) arrived on site and discovered the screen was not functioning.The display would light up and then go black.The iabp failed the fiber optic assembly test.The stm removed and replaced the display and fiber optic assembly.The iabp passed all functional and safety tests per factory specifications, was retuned to the customer and cleared for clinical use.
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