Merge hemodynamics monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.The system comprises the patient data module and the hemodynamics hemo monitor pc.The two units are connected via a serial interface.All vital parameters and evaluations are registered and calculated in the patient data module.This data is then transmitted to the hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the hemodynamics hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that problems were experienced with the ekg output to a volcano device.Information obtained from the customer revealed that the problem occurred while a transplant patient was sedated, and the procedure was delayed 20 minutes.It was also reported that the heart catheterization procedure was completed successfully; however, a flow wire study was attempted but cancelled due to the problem.The flow wire study will be completed at the patient's next visit - usually an annual visit unless problems present before then.It was further reported that the problem was not caused by merge hemo but rather a cabling issue with an external system.(b)(4).
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