MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems No Display/Image (1183); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A manufacture representative inspected the navigation system onsite and confirmed the reported issue.When turning on the navigation system from an off position, the system would appear on, however the staff cart screen showed no signal.The representative removed the old computer, installed a new one that has digital visual interface (dvi), and video graphics array (vga) ports.All connections were checked, and when powering up there was no signal.The representative attempted to plug the video adapter into itself without resolution.The new computer was removed and the original was put back in.The cords were arranged and the computer operated effectively.All applications were tested and performed as expected.The computer was returned to the manufacturer for evaluation.No fault was found with the returned computer.All tests passed and no errors were found.

Event Description

Information was received from a manufacturer representative regarding a navigation system outside of a procedure.It was reported that the monitors were flickering.There was no patient present when this issue was identified.

• Brand Name: STEALTHSTATION S7 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7409850
• MDR Text Key: 104841142
• Report Number: 1723170-2018-01555
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2015
• 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