The suspect hardware component is a ups, tripp lite 1000va, and a replacement was shipped from merge healthcare's (b)(4) site to the customer in february 18, 2016.The actual hardware was returned by the customer.Upon completion of the evaluation, no unusual noises were heard but the batteries appeared to be bad.
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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 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 hemo monitor pc via the serial interface.All data can be shown and monitored on the hemo monitor pc.On 02/15/2016, a customer reported to merge healthcare that when the site's medical staff was abstracting data, the uniterrupted power source (ups) started making a "ticking" sound.A report of an overheated/malfunctioning ups can lead to a potentially hazardous situation for users and/or patients.The customer confirmed that there was no patient involvement and no user harm was reported.(b)(4).
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