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

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.

• Brand Name: FUSION NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL 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 Key: 7408656
• MDR Text Key: 105173412
• Report Number: 1723170-2018-01545
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 04/18/2018; 07/27/2018
• Supplement Dates FDA Received: 05/14/2018; 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1