(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 04/06/2015.A document assessment ((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).Serial # corrected to (b)(4).Device manufacture date corrected to 07/03/2007.The sample was returned for evaluation.A visual exam was performed and no issues were observed.Functional testing was performed and the unit passed the initial power connect test and the power-on self-test (p.O.S.T.) with no issues.During the functional bench test, the unit successfully negotiated all pre-operational self-tests again and was functioning real time.After running for 1 hour, the unit dropped out.Multiple attempts were made to restart the unit, however, they were unsuccessful.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint was confirmed.The failure is indicative of a defective power supply pcb.All units being returned for service will have power supply pcbs replaced.This unit was manufactured 04 january 2007 and will be replaced.
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