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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number FUSION
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Patient Involvement (2645)
Event Date 03/19/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A manufacturer representative went to the site to test the equipment. Testing revealed that the computer for the navigation system was replaced to restore functionality. The system then passed the system checkout and was found to be fully functional. The suspect computer of the navigation system has been received by the manufacturer for evaluation. However, results are not available at this time.
 
Event Description
A manufacturer representative reported that, while outside of a procedure, the navigation system became unresponsive between ear, nose & throat (ent) procedures. It was noted the navigation system took fifteen minutes to log out of the application software. There was no patient present when this issue was identified. No additional information was provided.
 
Manufacturer Narrative
The computer was returned to the manufacturer for analysis. Testing found the computer had multiple ram errors and a loose connector. 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.
 
Manufacturer Narrative
Analysis was performed on parts that were replaced and analysed for a different event on this system. Due to the nature of the returned parts, it is reasonable to suggest that the issue in this event is related to returned and analysed parts. The axiem box was returned. Functional testing was unable to replicate the issue and the part was found to be fully operational. The axiem cable was returned. Continuity testing was performed and no open shorts were detected. The cable was found to be fully operational. The power supply unit was returned. Functional testing discovered that when the power supply was connected to ac, the power supply powered up with the fan running, but there was no output for any of the ports.
 
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Brand NameFUSION NAVIGATION SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
parker desautel
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7408656
MDR Text Key105173412
Report Number1723170-2018-01545
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFUSION
Device Catalogue Number9733560XOM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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