(b)(4).Additional information received from the customer indicates the issue was detected prior to use on a patient, during set up.The sample was returned for evaluation.A visual exam was performed and there were no defects observed.Functional testing was performed and the unit was connected to 110vac.The unit passed the initial power connect test and navigated through the power-on self-test (p.O.S.T.) with no issues.During the temperature display accuracy test the unit displayed the correct temperatures and properly alarmed in the high temperature scenario.The unit was prepared for the functional bench test where water, an adult breathing circuit (880-36kit), 2-3 lpm of air pressure, and a 382-10 concha smart water column was connected to the unit for a real time operational scenario.In addition to the named test parameters, the neptune operational values were set as follows: temperature was set at 37 c, mode was invasive, full rainout on the moisture scale.The neptune was turned on, values set.The unit successfully negotiated all pre-operational self-tests again and was functioning real time.The unit heated up to the set temperature and did not overheat.The unit functioned without any interruption or functional anomalies for approximately 1 hour.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.If the proper setup as described in the ifu is not followed, it may lead to heat build-up or high temperature.For example, insufficient water, insufficient gas flow or covering the circuit with materials such as blankets and sheets may cause the column to overheat.These are all described in the ifu.
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