Date of event: (b)(6) 2018.Date of report: 01july2019.The manufacturer's field service engineer (fse) was dispatched to the site and confirmed the reported problem.The pcba, tahoe user interface and pack and tahoe battery were replaced.The ventilator passed all testing and operated within the manufacturing specifications.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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