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 fse replaced the batteries and the checks were completed on the preventive maintenance.The iabp passed all functional and safety tests per factory specifications and 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, and has the following contact information: (b)(6).(b)(6) but only the first name was inserted due to the contents exceeding maximum characters.
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