Date of event: (b)(6) 2018.Date of report: 10july2019.The field service engineer (fse) replaced the blower assembly and harmony valve assembly to resolve the issues.The fse ran a system run-in, calibration and full performance verification.All tests passed successfully.This sleeve (flow) valve was returned and tested, no failures were identified.This bipap focus blower assembly was tested and no functional failures were identified.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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