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 hot and emitted a burning odor.Information obtained from the customer revealed that the user shutdown the computers, removed the ups unit, and bypassed the power supply to the hospital power outlets.It was reported that no patient was present when the ups failed.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 user harm.(b)(4).
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