(b)(4).The sample was returned for evaluation.A visual exam was performed and the back mounting bracket was found to be cracked.No other issues were 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 universal 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.The settings were set to full rainout, invasive, at 37 degrees c.The unit functioned without any interruption and was able to heat up to the set temperature of 37 degrees c.The water reservoir was emptied, and the unit was set up again for a functional bench test.The low water indicator light came on before the unit was able to heat up to 37 degrees c.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.
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