In discussion with the customer, they were unsure of the dates of the incidents or how many times the issue occurred.The customer noted that all procedures were completed successfully.A review of internal records dating back to 1/1/2016 revealed no prior call-in's regarding this issue.Merge healthcare support shipped the customer a cabling bracket, that upon installation, eliminated the cabling disconnects.
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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 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 hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the hemodynamics hemo monitor pc.On (b)(6) 2016 a customer reported to merge healthcare that during several catheterization procedures their hemo vitals monitor was "blacking out or not being able to see vitals and waveforms" due to a disconnected trunk cable.This results in the inability to capture and document patient vitals within the hemo client pc chronlog.With merge hemo not presenting physiological data during treatment, there is a potential for delay in treatment that could result in harm to the patient.However, the customer stated that all of the affected procedures were completed successfully upon re-seating the cabling.(b)(4).
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