Date of event: (b)(6) 2018.Date of report: 09/17/2019.The manufacturer¿s international service technician replaced the data acquisition (da) pcba to address the reported problem.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.Failure analysis of the returned part indicates: no fault found.All testing performed within specification.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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