MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number	9735602
Medical Device Problem Codes	Mechanical Problem (1384); Human-Device Interface Problem (2949); Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.E) initial reporter not known at the time of reporting.The computer was returned to the manufacturer for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The communication between the axiem and the returned computer was intermittent.After communication was established, it was lost, then it would regain a short time later.Changing the uninterruptible power supply (ups) ports did not effect the behavior.A computer failure was observed.The manufacturer representative went to the site to test the navigation system.They exchanged the compact computer.The investigation is ongoing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported outside of a procedure that he manufacturer representative (rep) was unable to establish communication with the system.The navigation light on the axiem box would not illuminate.The rep restarted the system multiple times with the systems separated and was able to get normal behavior only a couple times.Eminterface would sometimes be available and sometimes would not be.The emitter would also randomly stop communicating if the rep was able to get the axiem box to begin communicating.No patient was present at the time of the event.
Additional Manufacturer Narrative
The computer was sent to the vendor for analysis.Vendor analysis found that the failure could not be confirmed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Initial reporter received.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported outside of a procedure that he manufacturer representative (rep) was unable to establish communication with the system.The navigation light on the axiem box would not illuminate.The rep restarted the system multiple times with the systems separated and was able to get normal behavior only a couple times.Eminterface would sometimes be available and sometimes would not be.The emitter would also randomly stop communicating if the rep was able to get the axiem box to begin communicating.No patient was present at the time of the event.

• Brand Name: FUSION COMPACT
• Common Device Name: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8275287
• Report Number: 1723170-2019-00401
• Device Sequence Number: 13874511
• Product Code: PGW
• UDI-Device Identifier: 00643169672956
• UDI-Public: 00643169672956
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K153247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/25/2019; 02/26/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/15/2019; 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1