G4: 09jan2020 b4: (b)(6) 2020.The manufacturer¿s field service engineer (fse) confirmed the reported touch screen issue.The manufacturer¿s field service engineer (fse) replaced the touch screen to address the reported problem.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.No parts returned to failure investigation; therefore, the root cause of the reported issue could not be determined.If parts are returned, the complaint will be reopened and an investigation will be performed.The determination could not be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.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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