Model Number FUSION |
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 Known Impact Or Consequence To Patient (2692)
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Event Date 05/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device manufacturing date and udi is unavailable.A medtronic representative went to the site to test the equipment.After testing, isolation transformer and power cable were replaced.The system then passed the system checkout and was found to be fully functional.The suspected isolation transformer was returned to the manufacturer for analysis.Analysis found that there was no physical damage, and no issue found.Unable to replicate the issue.The suspected main cable was returned to the manufacturer for analysis.Analysis found that the cable passed a continuity test with no opens or shorts detected.Unable to replicate the issue.
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Event Description
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Medtronic received information regarding a navigation system.It was reported that intra/peri-operatively during the navigate task of a functional endoscopic sinus surgery (fess) procedure, the system rebooted on its own twice.A manufacturer representative checked out the isolation transformer and all connections seemed fine.The representative was unable to replicate the issue.It was noted that the power cable had some abnormalities.The procedure was successfully completed with a delay of approximately 20 minutes.There was no reported impact on patient outcome.
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Manufacturer Narrative
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Additional information: device manufacture date provided.Product, unique device identification (udi) and related fields updated to proper value.
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Search Alerts/Recalls
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