During a preventative maintenance (pm) service, the getinge field service engineer (fse) discovered the drive manifold was defective on the cardiosave intra-aortic balloon pump (iabp) unit.To fix the issue, the fse replaced the drive manifold assembly.Unrelated, the fse also replaced a 9v daughter board battery, recorder paper roll and a damaged fiber optic connector, and then performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.(b)(6).
|