Date of event: (b)(6) 2018.Date of report: 17sep2019.The manufacturer¿s international service technician confirmed the reported airflow issue.The manufacturer¿s international service technician replaced the flow sensor assembly to address the reported problem.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.Airflow sensor drift caused unit to pass out of specified range.Replacement of u1/u2 combination of airflow sensor subsystem resulted in the unit passing all testing.Root cause failure determined to be fault in u1 of airflow subsystem.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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