Date of event: (b)(6) 2018.Date of report: 18jul2019.Replaced blower and flow valve assy.Ran system calibration and performance verification and all testing passed.The device was evaluated by the failure investigation lab.The failure investigation lab was unable to duplicate the reported issue and because no malfunctions were observed no repairs were made.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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