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 "phantom" locks appeared on three (3) tabs in the hemo application.The problem occurred while a procedure was in progress and prevented the user from entering patient data.The affected tabs included the patient/data study, history, and hemodynamics.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 accessing the database and resetting the locked tabs so that they became editable after replication.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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