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) 2016, a customer reported to merge healthcare that tabs were locked out on a patient's study and the medical staff could not edit them.These tabs included patient/study data, staff, and chronlog.Depending on which tab is locked, it could prevent a calculation from computing correctly if the patient's data, such as height and weight, are in a locked state.It could also prevent the patient study from promptly being confirmed.This could pose a potential risk to the patient caused by a delay in treatment.However, it was confirmed that merge healthcare resolved the problem by resetting the database.The customer did not allege or indicate that the patient was at risk of serious injury.To date, merge healthcare has not received allegations of a serious injury because of this reported problem.(b)(4).
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