Model Number FUSION COMPACT |
Device Problems
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Erratic or Intermittent Display (1182); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/27/2017 |
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 site to test the equipment.Representative reported that a computer was replaced to resolve the issue.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect computer has not been received by the manufacturer for evaluation.
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Event Description
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A medtronic representative reported that, while outside of a procedure, the navigation system monitor would display there was no input when starting up the system.It was reported that after cycling power to the system a few times, functionality was restored.Representative mentioned that the display was flickering intermittently and the software would become unresponsive.Rebooting the system resolve the issue.There was no patient present at the time of the issue.
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Manufacturer Narrative
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The computer for the navigation system was returned to the manufacturer for analysis.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.
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Search Alerts/Recalls
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