(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no defects observed.The unit was gently rotated and then lightly shaken to determine if any loose components might be moving around inside the plastic case.Nothing loose noted.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), 10 lpm of air pressure, and a 382-10 universal water column is connected to the unit for a real time operational scenario.The unit functioned without any interruption or functional anomalies for approximately 3.0 hours.A device histo ry record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.
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