Date of event: (b)(6) 2018.Date of report:0 5aug2019.Ts recommended changing out the data acquisition (da) pcba.Through follow up, customer confirmed that replacement of the da pcba resolved the reported issues.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 submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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