The production device history record (dhr) for this intra-aortic balloon pump (iabp) 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.During a pm service, the getinge field service engineer (fse) discovered defective pixels at the top of the screen display which was obscuring the data.To fix the issue, the fse replaced the display.The unit was then calibrated and passed all function and safety tests per factory specifications.The iabp was then released to the customer and cleared for clinical service.The full name of the initial reporter is (b)(6).He is a getinge employee who has different contact details from that of the event site as follows: (b)(6).
|