MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BI70002000
Medical Device Problem Codes	Positioning Problem (3009); Unintended Movement (3026)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device manufacturing date is unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that the imaging acquisition system (ias) did not drive or boot up normally.The generators were disassembled from dock position and the power conversion enclosure was replaced.The imaging system then passed the system checkout and was found to be fully functional.The power conversion enclosure (rev.3 : s/n (b)(4)) was returned for analysis.Analysis found that the power conversion enclosure failed bench testing.Transistor q1 and diodes d4 and d6 had failed due to electrical shorts.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an imaging device being used outside of a procedure.It was reported that the imaging device lost motion power.A manufacturing representative (rep) was able to manually push the system, but could not do lift and shift to re-create the system.The motion batteries were showing full.It was noted that the system was on a cadaver truck and that there was no patient involvement.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• MDR Report Key: 8384701
• Report Number: 3004785967-2019-00335
• Device Sequence Number: 11275598
• Product Code: OWB
• UDI-Device Identifier: 00643169980976
• UDI-Public: 00643169980976
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K151000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2019

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: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2019
• Initial Report FDA Received Date: 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1