(b)(4).The sample was returned for evaluation.A visual exam was performed and a crack in the rear mounting bracket was observed.No other defects were 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.When an attempt was made to change modes, the "accept" button did not illuminate.The unit still functioned properly and was able to change modes, but the button did not illuminate on the user interface panel.The unit was prepared for the functional bench test where water, an adult breathing circuit (880-36kit), 2-3 lpm of air pressure, dual temperature probes, and a 382-10 concha smart water column was connected to the unit for a real time operational scenario.The unit successfully negotiated all pre-operational self-tests again and was functioning in real time.All settings could be adjusted on the unit.The settings were set to full rainout, invasive, at 37 degrees c.The unit functioned without any interruption.The complaint of not being able to change the settings could not be confirmed.However, during functional testing the "accept" button on the user interface panel was found to not illuminate.The button was still able to function and the modes could be changed on the unit.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 2010 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 the light failure.Teleflex will continue to monitor and trend on complaints of this nature.
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