Date of event: (b)(6) 2017.Date of report: 04sept2019.The manufacturer's field service engineer confirmed the reported problem.The manufacturer's field service engineer determined that the replacement of the blower, flow valve and controller printed circuit board (pcb) was required to address and correct this reported event.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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