Date of event: (b)(6) 2018.Date of report: 09july2019.All pressure reading is out of spec -reading low.Unable to complete a system calibration.Replaced blower and flow valve assy.Replaced controller pca.Reloaded system software ran system calibration.Ran performance verification ,all testing passed.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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