MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9734060
Medical Device Problem Code	Environmental Compatibility Problem (2929)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 9735226r, serial/lot #: (b)(4), ubd: unknown, udi#: unknown.A medtronic representative went to the site to test the equipment.Testing revealed that parts were replaced, and the issue resolved.The system then passed the system checkout and was found to be fully functional.The computer was returned to the manufacturer for analysis.Analysis found that the reported issue could be duplicated.During initial power up, the computer froze on the load operating system boot text.Testing found errors and the computer failed ram memory testing.The computer had a bad ram memory module.Analysis found that the reported event was related to a computer component issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.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 that when the equipment started, none of the screens showed anything.They stayed showing "dvi searching" and there was no signal coming from the black box.There were monitors with fiber connections and dvi connections but none was receiving image.The monitor that stayed inside the black box didn't received signal as well.It was suspected that the problem was the optical transceiver but the dvi's monitors were not working as well.Because of this, it was suspected that the problem could be the computer or at the first dvi splitter.There was no patient present when this issue was identified.Technical services (ts) requested that the dvi splitter, multiout power supply, and computer outputs be checked.An update was provided that the multiout power supply was ok.It was reported that the problem was the computer; it could not stay on.When the system was started, the computer started and stayed on for less than five second and then rebooted.It was noted that after some second, it rebooted again and again.The computer of the system was replaced, and the issue resolved.

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8702276
• Report Number: 1723170-2019-03376
• Device Sequence Number: 2446212
• Product Code: HAW
• UDI-Device Identifier: 00643169486645
• UDI-Public: 00643169486645
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2019

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: 9734060
• Device Catalogue Number: 9734060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 06/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1