(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no major defects observed.Functional testing was performed and the unit was connected to 120vac.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 a water reservoir bottle, an adult breathing circuit (880-36kit), a 382-10 conchasmart column, and dual temperature probes were connected to the unit.Air flow was supplied to the unit for a real time operational scenario.The unit successfully navigated all pre-operational self-tests again and was functioning in real time.The settings were set to full rainout, invasive, at 37 degrees c.The unit functioned for a few seconds but then powered off.The power button was pressed but the unit would no longer pass p.O.S.T.The unit was opened and the power supply board was replaced with a known good power supply board.This time the unit successfully navigated all pre-operational self-tests again and functioned without any interruption or functional anomalies for ~1.0 hour.The complaint has been confirmed.The investigation revealed a defective power supply board.Since the neptunes are 100% functionally tested during manufacturing assembly, it is unlikely that the failure was present at the time of release.A device history record review was performed with no evidence to suggest a manufacturing related issue.The unit was manufactured in 2012 and was designed for a minimum of 5 years.The root cause for the failure is normal wear.Teleflex will continue to monitor and trend on complaints of this nature.
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