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 Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Onsite functional and visual examination was performed by a manufacturer representative.The system passed a system checkout and was determined to be fully operational.
Event or Problem Description
Medtronic received information regarding an imaging device being used outside of a procedure.It was reported that the tracker is not recognized by the igs.There was no patient present when this issue was observed.
Additional Manufacturer Narrative
Analysis on the returned gantry motor control resulted in an electrical failure being found through functional testing and visual/physical examination.Analysis states that, installed motion control box into test system 267.Turned the system on, the system locked up with "initializing system please wait" and motion would not ready.Faulty motion control box.If information is provided in the future, a supplemental report will be issued.

• 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: 7890012
• Report Number: 1723170-2018-04831
• Device Sequence Number: 2365408
• 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,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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: Health Professional
• Device Model Number: BI-700-00028-120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1