Communication between merge healthcare and the customer revealed that the site does not routinely zero channel 3 and is likely that the ffr action editor was set incorrectly.It was also noted that the third party transducer was subsequently replaced.Hemo 10 user manual, addresses the potential for such an occurrence by statements such as, "in order to calculate ffr, the blood pressure proximal to a lesion must also be measured.A standard pressure transducer device is required.The standard pressure transducer used in the cardiac catheterization laboratory converts a column of fluid (pressure of the patients' arterial or venous system) into an electronic signal using a strain gauge that is then displayed on the hemodynamic monitor.The transducer should be zeroed at the beginning of every study as a precaution whenever a pressure displayed on the screen is suspect, or any time a new transducer is connected to the hemodynamic system." for this reason, conclusions code (failure to follow instructions) was used.
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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 integrated ffr (fractional flow reserve) would not equalize during a procedure.This resulted in a 15 minute delay.With merge hemo not capturing physiological data, there is a potential for incorrect treatment that results in harm to the patient.However, the customer reported that the procedure was completed successfully using a third party ffr device.Reference complaint number (b)(4).
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