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 merge 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 merge hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the merge hemodynamics hemo monitor pc.On (b)(6) 2017, a customer reported to merge healthcare that the ups (uninterrupted power supply) was clicking and presented two (2) yellow led lights.The problem was found first thing in the morning when the medical staff was setting up the lab.If parts of the hemo system become energized, there is a potential for direct harm to the patient and/or user including electrical shock or burns.However, there was no report of injury to the staff as a result of the ups failure.(b)(4).
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