(b)(6), biomed, placed subject call.Beck identified console not fully latched into the cart.(b)(4) secured console into hospital cart and physically observed and monitored unit charging batteries as intended.A getinge field service engineer (fse) was dispatched to evaluate the iabp and was unable to reproduce the reported issue.On (b)(6), unit ran on battery 1 from 0719 to 0855, registering 0 capacity at that time.Unit switched to battery 2 at that time.Unit subsequently shows batteries charging without issues, as reported by end user.Full calibration, functional, and safety checks were performed which passed to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) went into battery mode.Therapy was continued on this unit without issues and monitored by perfusionist from (b)(6) 2021.No patient harm, serious injury or adverse event was reported.
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) went into battery mode.Therapy was continued on this unit without issues and monitored by perfusionist from (b)(6) 2021.No patient harm, serious injury or adverse event was reported.
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