Model Number S7 |
Device Problems
No Display/Image (1183); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/23/2017 |
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.No evaluation has been performed as confirmation has not been provided by the site to have a medtronic representative perform a system checkout and evaluation.No parts have been returned to the manufacturer for evaluation.
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Event Description
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A site representative reported that outside of a procedure the surgeon monitor on the navigation system was observed to be broken.The surgeon monitor displays a picture for 3 seconds and then the monitor goes black.There was no patient present when this issue was identified.
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.The representative reported that the monitor of the navigation system would power down without prompt from the user.The monitor was then replaced by the representative.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect monitor has not been received by the manufacturer for evaluation.
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Manufacturer Narrative
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The monitor for the navigation system was returned to the manufacturer for evaluation.Testing found that the monitor would lose display functionality after a few seconds.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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