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) was dispatched to investigate and verified the reported issue.Additionally, the stm observed that error code 63 was logged multiple times in the diagnostics, which is an indication of touchscreen failure.To resolve the issue, the stm replaced the video receiver board, but after replacement the video noise was still present.The stm then replaced the upper display monitor board which resolved the issue.In addition, all related labels for the upper display were replaced and all calibration, functional and safety tests were performed and passed per factory specifications.The iabp was returned to the customer and cleared for clinical service.
|
It was reported that during a service/test performed by the customer, the display on the cardiosave intra-aortic balloon pump (iabp) was distorted.It was later reported that the upper display had video noise in the background of the display, but all normal information was still visible.There was no patient involvement and no adverse event was reported.
|