Date of event: (b)(6) 2018.Date of report: 16sep2019.The manufacturer's field service engineer (fse) confirmed the reported issue.The replaced tui pc board and battery.Unable to finish repairing this device because error 29 is a defective controller board.This board has reached the end of its life cycle and there is no more in stock.Returning device to customer who will replace the controller board which will resolve the issue.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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