Date of event: (b)(6).Date of report: 23aug2019.The manufacturer¿s field service engineer (fse) replaced the defective blower and harmony valve to address the reported problem.The unit successfully passed the required performance verification test.Failure analysis of the returned part indicates: the returned blower assembly and sleeve valve assembly were tested and no failures were identified.The flow valve assembly was tested and it was determined physical damaged resulted in the jammed sliding valve and cracks.This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.
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