Date of event: (b)(6) 2018.Date of report: 25jul2019.The customer attempted to install a new battery and that did not resolve the issue.The manufacturer's field service engineer confirmed the reported customer complaint.The manufacturer¿s field service engineer (fse) replaced the defective user interface pca and battery to address the reported problem.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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