Date of event: (b)(6) 2018.Date of report: 11sep2019.The product support engineer advised the customer to replaced the flow sensor to address the reported issue.Root cause: failure analysis on the returned gas delivery system shows that this customer complaint was caused by an out of spec air flow sensor u1.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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