Model Number S7 |
Device Problems
Computer Software Problem (1112); Device Inoperable (1663); Application Program Problem (2880)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/06/2018 |
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 parts have been returned to the manufacturer for analysis.Device manufacture date is not available at time of filing.A medtronic representative went to the site to test the equipment.Testing revealed that the system regained functionality upon replacement of the central processing unit (cpu), however the computer was not returned to the manufacturer for analysis.Systems checkout was performed and system was functioning as intended.
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Event Description
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Medtronic received information regarding a navigation device being used for outside a procedure.The issue occurred preoperatively.It was reported that the computer was becoming unresponsive whenever they attempted to import exams.There was no patient present when this issue was identified.
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Manufacturer Narrative
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Device manufacture date provided.Correction: product, unique device identification (udi) and related fields updated to proper value.No 510(k) provided as this device is not released for distribution in the united states.The computer for the navigation system was returned to the manufacturer for analysis.The computer 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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