Date of event: (b)(6) 2018.Date of report: 09aug2019.Technical support provided the part number for fan guard, filter & retainer to the customer.The customer replaced the affected parts to address the issue.The device successfully passed the performance verification testing after the repair was completed.The ventilator was put back in service with no additional 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.
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