Date of event: (b)(6) 2018.Date of report: 09sept2019.The biomedical engineer confirmed the reported issue.The biomedical engineer unplugged all the pipes on the machine ,then the machine could be set to standby.The unit successfully passed the required performance verification test.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.Customer resolved.
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