(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the device was not returned at the time of this report.The device history record (dhr) review did not show issues related to the complaint.The device was manufactured on 02/09/2015.A document assessment (fmea (b)(4)) was conducted and no changes were required.The reported complaint cannot be confirmed since the device sample is not available to perform a proper investigation, determine the root cause and assign corrective actions.If the device sample becomes available at a later date, this complaint will be updated accordingly.
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(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was performed and the unit was connected to 110 vac.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 neptune displayed the correct temperatures and properly alarmed in the high temperature scenario.In order to confirm the complaint, a small amount of sterile water was primed into the 382-50 universal water column which raised the water level float in the column.The neptune was turned on and was setup for invasive treatment, heavy rainout, and a max temperature of 37 degrees c.As the temperature on the column began to quickly rise, the paper medium in the column started absorbing the water.As the water was being absorbed, the water level float inside the column was moving to the bottom.Once the water level float had fallen to the bottom of the column, the magnetic sensor on the neptune was activated and the low water warning light was displaying on the front panel.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing of the returned unit did not reveal any operational anomalies.
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