Model Number FUSION |
Device Problems
Computer Software Problem (1112); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A medtronic inspected the navigation system onsite and confirmed the computer rebooted on its own and froze several times.It was not possible to un-install and reinstall the software successfully.Computer replacement required.No parts have returned to the manufacturer for evaluation.
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Event Description
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A medtronic representative reported that while in a functional endoscopic sinus surgery (fess) procedure the navigation system became unresponsive while beginning to navigate again.The site had been navigating without issue, then did not use navigation for approximately 10 minutes.It was reported that they returned to start tracking an instrument when the system became unresponsive.The representative trouble shot the system which hung on the ear, nose & throat (ent) blue screen for a few minutes.A hard shutdown of the system was performed and it was possible to successfully launch ent application and proceed into navigation.There was a reported delay to the procedure of less than 1 hour due to this issue and no impact on the patient outcome.
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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 computer of the navigation system was replaced.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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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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Manufacturer Narrative
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Patient identifier field not sufficient to hold all digits, should read: (b)(6).Correction: patient demographics inadvertently not included on previous mdr report.
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Manufacturer Narrative
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The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.
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Search Alerts/Recalls
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