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 Patient Involvement (2645)
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Event Date 03/27/2018 |
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.Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that the cd drive of the navigation system was replaced to restore functionality after the reported issue could be replicated.The system then passed the system checkout and was found to be fully functional.The cd drive was returned to the manufacturer for analysis.Analysis found that the drive did not affect the computer of the navigation system but could not read known operational discs.Analysis found that the reported event was related to a electrical issue.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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Event Description
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Medtronic received information that, while outside of a procedure, the navigation system was unable to start up twice.When a cd was inserted into the navigation system, the application software would become unresponsive and not display any indications of the patient's archive being loaded.A hard restart of the navigation system was required.The exam could then be loaded on a separate medtronic navigation system.There was no patient present when this issue was identified.No additional information was provided.
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Manufacturer Narrative
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Additional information: unique device identification (udi) and device manufacture date updated to proper value.
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Manufacturer Narrative
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A software investigation analysis was initiated to determine the probable cause of the issue through review of the reported issue.Analysis found that the hard drive of the navigation resulted in the reported issue.Analysis found that the software functioned as designed.
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Search Alerts/Recalls
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