The production device history record (dhr) for this iabp unit 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 getinge stm that found the issue replaced the fiber optic module assembly and the problem was resolve.The stm then performed all functional and safety test as per factory specifications.The iabp was then returned to the 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, and has the following contact information: (b)(4).
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