Model Number S7 |
Device Problems
No Display/Image (1183); Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Representative confirmed that the system was booted multiple times and the issue could be replicated.
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Event Description
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Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the system displayed no input detected on the staff monitor while the surgeon was blank.Issue occurred while exiting the cranial application.Site reported that this has happened during boot as well.Manufacturer representative confirmed that video splitter was getting power but not signal.Fan guard was removed and the system began to boot.Cables were reseated and readjusted.There was no patient present when this issue was observed.
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.Testing revealed that the computer for the navigation system was replaced to restore functionality.The system then passed the system checkout and was found to be fully functional.The computer for the navigation system was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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