Date of event: (b)(6) 2018.Date of report: 13sep2019.The pse was able to confirm the reported issue.The pse performed operational check then green led of power switch had illumination failure so the power switch overlay was replaced.During pm, the pse replaced the power switch overlay to address the issue of power switch led failure.The pse also replaced as part pm the unit's oxygen inlet filter, blower assy., lithium-ion battery, cooling fan and tubing kit.Unit was tested and passed.No parts were returned for failure investigation 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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