(b)(4).A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A device history record review was conducted no issues were found related to the complaint.A document assessment (fmea) was conducted and no changes required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time since the device sample is not available, it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed since the device sample is not available to perform a proper investigation and determine the root cause.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 also performed and the unit passed all tests; however, the current test could not be conducted since the thermal cutoff was open and the unit did not heat up.It is possible that the damage was due to overheating of the unit.Based on the investigation performed, the reported complaint was confirmed.Although the complaint was confirmed, a root cause for the issue could not be established.All aquatherm units are 100% tested at the manufacturing facility; therefore, a defect of this type would be detected prior to release.A conclusion code could not be chosen as the complaint was confirmed; however, a root cause could not be determined.
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