Model Number FUSION |
Device Problems
No Display/Image (1183); Application Program Problem (2880)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/17/2018 |
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.Udi not available at the time of filing.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 dicom qr application was not installed.Application installed and exams transferred.Unable to recreate issue.
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Event Description
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Medtronic received information that the monitor on this navigation system went black when the site attempts to query for a patient.They then are required to reboot the system and after rebooting, the same behavior happens.Verified the cabling is properly seated.This black screen only occurs when they attempt to query.Unique to dicom qr application.There was no patient present when this issue was identified.
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Manufacturer Narrative
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Additional information: unique device identification (udi) and device manufacture date provided.Correction: product and related fields updated to proper value.
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Search Alerts/Recalls
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