(b)(4).The device involved in this complaint was not returned to the manufacturer at the time of this initial report.A verification of failure mode reported in the current manufacturing process was conducted.Eleven devices were taken from the current production p/n 050-14 aquatherm iii,electronic heater lot # 73g180001n.Samples were functionally inspected, and during the test issue reported "dial does not turn prior to use" was not observed in the current manufacturing process.Trending history review shows for period (b)(6) 2017-(b)(6) 2018 one complaint received with similar issue.A record assessment (fmea) was conducted and no update is required.Customer complaint cannot be confirmed at this time.If the device sample becomes available at a later date, this report will be updated with the evaluation results.
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(b)(4).One (1) unit of catalog number: 050-14 (aquatherm iii , electronic heater), serial number: (b)(4), was received for analysis.It was found that the knob turns freely and stops at the minimum and maximum value.Functional testing was performed and the unit passed all tests conducted.The unit was tested (heating) placing the potentiometer on the three positions: minimum, medium and maximum.As result, it was observed that the unit does not heat in the three positions; temperature was maintained in 22.8 c.Then the sample was opened (housing) and during the evaluation it was detected that the pcb was damaged.It is not known how the damage occurred.A device history record review was performed on the lot number of the sample received and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint of "dial does not turn prior to use" could not be confirmed.It was found that the knob turns freely and stopes at the minimum and maximum values.All products are 100% tested at the manufacturing facility; therefore, any defects would be detected prior to release.
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