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

Model Number	BI70000028120
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not available on the date of filing.A manufacturer representative went to the site to test the equipment.User complained about the system shutting down on its own.Performed three mock cases (6+ 2d and 3 3d scans) without issue.Reviewed error logs and couldn't locate when the problem occurred.Rt confirmed the date and time but no issues were noticeable.The imaging system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an imaging system.It was reported that intra/peri-operatively during the select patient/acquire scans task of a sacroiliac and thoracolumbar procedure there was a mobile view station (mvs) and image acquisition system (ias) shut down while setting up for a 3d spin.Rebooting both systems fixed this issue and the site was able to proceed with the case.It was reported that the patient was exposed to one additional imaging spin.There was a delay to the procedure of less than one hour.There was no reported 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 st; littleton MA 01460
• MDR Report Key: 8861309
• Report Number: 3004785967-2019-01377
• Device Sequence Number: 2753624
• Product Code: OXO
• UDI-Device Identifier: 00643169845091
• UDI-Public: 00643169845091
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

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: BI70000028120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 118