Updated fields: b4, d9, e1 (site country), g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, component code, investigation conclusion), h10, h11.It was reported that the cardiosave intra-aortic balloon pump (iabp) unit safety disk was due for replacement.A getinge field service engineer (fse) replaced with a new one serial number: (b)(6) but it failed on membrane diff prs.(mmhg) parameter.After replacing with another safety disk the membrane diff prs.(mmhg) parameter was passed within specifications.The patient involvement is unknown.
|