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 the hemo client pc would not power up.Most often, the procedure is not interrupted when the client pc does not operate correctly because the hemo monitor continues to function as intended.However, in this case, the site elected to have the study rescheduled for the patient.Due to the failure of the hemo client pc to function as expected, there is a potential for a delay in diagnosis and/or treatment.(b)(4).
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