(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 except for the current test.It was found that the thermofuse was damaged.Based on the investigation performed, the reported complaint of "unit failed" was confirmed.Although the product showed the defect, a corrective action could not be established due to the fact that all aquatherm heaters 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 was not established.
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