Date of event: (b)(6) 2018.Date of report: 30july2019.Per customers request field service engineer (fse) was dispatched to the site and confirmed the reported problem.The customer replaced the defective user interface board to address the reported problem.Fse ran real-time check and system calibration.Ran battery runtime testing.Ran performance verification ,all testing passed.The unit successfully passed the required performance verification test.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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