Date of event: (b)(6) 2019.Date of report: 01jul2019.The unit was evaluated by the manufacturer's field service engineer (fse), and the reported issue was confirmed.The fse found a bad board on unit.The board is no longer available.The unit was returned to the customer, and was not repairable.The determination could not be made that the device failed to meet specifications.The device was not being used on a patient.No parts were returned to failure investigation; therefore, the root cause of the reported issue could not be determined.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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