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 getinge service territory manager (stm) re-sat the cables and connections, however this did not resolve the issue.The stm then replaced the lcd and display and it continued to not display the colors properly.The tm returned at a later date and replaced the display controller resolving the issue.The stm then completed the calibration and performed all functional and safety tests which passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.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: (b)(6).Full event site name: (b)(4).
|