Date of event: (b)(6) 2018.Date of report: 09/17/2019.The manufacturer's field service engineer (fse) confirmed the reported issue.The manufacturer¿s field service engineer (fse) replaced the defective user interface board, battery and membrane panel address the reported problem.The unit successfully passed the required performance verification test.No parts were returned to failure investigation; therefore, the root cause of the reported issue could not be determined.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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