Event date: (b)(6) 2018.Date of report: 18sep2019.Manufacturer's field service engineer (fse) performed troubleshooting with the customer and diagnosed it to be code ( pressure sensor failure).The field service engineer advised that the controller pcb (patient circuit board ) is no longer available due to eol (end of life) and provided eol documentation to the customer.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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