A getinge field service engineer (fse) evaluated the iabp, but was unable to reproduce the reported issue.The fse tested the unit without any issues.The fse performed full calibration, all functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.(b)(6).
|
It was reported that during a bypass surgical procedure, the cs300 intra-aortic balloon pump (iabp) alarmed "disconnect" error.It was also reported that the end user checked and secured all lines and connections, before ultimately switching to another maquet iabp unit, without any issues, to continue patient treatment.Further, the unit involved was sent to the biomedical customer awaiting evaluation.No patient harm, serious injury or adverse event was reported.
|