Date of event: (b)(6) 2018.Date of report: 01jul2019.The manufacturer's field service engineer (fse) performed onsite troubleshooting and confirmed the unit would not power on.The fse replaced the ventilator's 18v power supply to address the finding.The ventilator passed performance verification testing after the unit was repaired.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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