MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number	BI-700-00028-120
Medical Device Problem Codes	No Display/Image (1183); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not evaluated or return to the manufacturer as the issue was resolved over phone at the time of the procedure.The issue at the site was determined to be caused by the outlet of the hospital.
Event or Problem Description
Medtronic received information regarding an imaging device.It was reported intraoperatively that the mobile view station (mvs) kept shutting down and going completely black bypassing all the shutdown sequences while inputting patient information.The site plugged the mvs into a different outlet and the issue was resolved.The surgical delay was less than one hour.No impact on patient outcome.

• Brand Name: O-ARM 1000 IMAGING SYSTEM 3RD EDITION
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• MDR Report Key: 7594280
• Report Number: 1723170-2018-02738
• Device Sequence Number: 1775638
• Product Code: OXO
• UDI-Device Identifier: 00643169845091
• UDI-Public: 00643169845091
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K092564
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

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
• Operator of Device: Radiologic Technologist
• Device Model Number: BI-700-00028-120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2017
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 91