(b)(4).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 failed the initial power connect test as the appropriate indicator lights did not flash.However, no alarm was heard or observed.The power supply board was bypassed with a known good lab inventory board and this time, 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 functioned without any interruption or functional anomalies.The unit had a faulty power supply board.Once the power supply board was bypassed, no functional issues were observed and the unit heated up to the set temperature.The reported complaint of "unit is alarming" is not confirmed.However , a different defect was confirmed as the unit failed the initial power connect test.The sample was returned with a defective power supply pcba.A device history record review was performed with no evidence to suggest a manufacturing related issue.Each concha neptune device is inspected 100% during manufacturing assembly, it is unlikely that this defect was present at the time of release.The sample was manufactured in 2008 and was designed for a minimum of 5 years.Based on the information available, it appears that unintentional user error - normal wear caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.
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