MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9734894 S7 STAFF AXIEM ONLY 110V; INSTRUMENT, STEREOTAXIC

Model Number	9734894
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the system displayed " no signal" on a consistent basis after the site deleted patients from the system.Wilson disconnected the axiem box then restarted but it still displayed no signal.The was no patient present.The representative bypassed the video splitter and was unable to replicate behavior of monitors going in and out, was able to occasionally replicate with the video splitter connected.When the screens came back, they were at the splash screen indicating the computer is booting up and functioning.The staff cart had no signal while the surgeon cart had no display at all.The representative re plugged the interconnect cable between the two, and both screens now work as intended.

• Brand Name: CART 9734894 S7 STAFF AXIEM ONLY 110V
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8651225
• Report Number: 1723170-2019-02767
• Device Sequence Number: 19590555
• Product Code: HAW
• UDI-Device Identifier: 00643169105232
• UDI-Public: 00643169105232
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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: 9734894
• Device Catalogue Number: 9734894
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1