Qn#(b)(4).The sample was returned for evaluation.Upon receipt the disposable temperature probe set was visually inspected for any signs of abuse/misuse/damage.Nothing was noted.Functional testing was performed and the disposable temperature probe set was incorporated into a standard neptune bench test setup.The neptune was prepared for the functional bench test where water, an adult breathing circuit (880-36kit), 10 lpm of air pressure, a 382-10 universal water column, and an 872-dtp deposable temperature probe was connected to the unit for a real time operational scenario.The unit successfully negotiated all pre-operational self-tests and was functioning real time.The neptune test parameters were set as follows: operational mode was set to invasive, heated gas was set at 37 c, rainout was set to full scale to the right (heavy rainout).The unit, to include operation of the disposable temperature probe set, functioned without any interruption or functional anomalies for ~2.0 hours.The device history record of batch number 74l1900999 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-con formance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on the investigation performed, the reported complaint could not be confirmed.
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