Date of event: (b)(6) 2018.Date of report: 13sep2019.The product support engineer (pse) replaced the power switch overlay to resolve the reported issue.The pse also replaced as part pm the unit's blower assembly, lithium-ion battery, cooling fan, oxygen inlet filter, tubing kit, air inlet filter and cooling fan filter.The device passed all testing and operated within the manufacturing specifications.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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