Model Number S7 |
Device Problems
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/30/2017 |
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 been received by the manufacturer for evaluation but the results are not available yet.
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Event Description
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A site representative reported that while outside of procedure, the navigation system became unresponsive when attempting to threshold the image.Rebooting the system resolved the issue.There was no patient present at the time of the issue.
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Manufacturer Narrative
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The analysis of the computer of the navigation system was completed by medtronic personnel.Testing found that the memory test resulted in a bad ram module being discovered.When a new module was installed, the unit functioned as designed.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.
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Search Alerts/Recalls
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