Evaluation conclusion code 4307/cause traced to component failure 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) found the issue and replaced the batteries.The stm performed all calibration, functional and safety tests on iabp, which passed.The iabp 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.Please refer to the following email and phone number as contact information for the initial reporter: (b)(6).
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