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

Model Number	BI70002000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6): the manufacturing representative (rep) went to site to test the imaging system and confirmed issue of system going from 2d to stand alone and back to stand alone.Replaced power enclosure, power tray and charger enclosure.Tray and power tray were old style and needed to be updated.System passed all testing after part replacement.Site aware and system ready for use.Replaced umbilical and tested system, ready for use.System is operational.The component was returned to the manufacturer for analysis.Analysis found that confirm reported complaint, "standalone mode and 2d mode." continuity test passed and cable was installed in imaging system.Intermittent ias/mvs network connection was occurring by wiggling the umbilical cable.Faulty cable assembly.The component was returned to the manufacturer for analysis.Analysis found that unable to confirm reported complaint."o2 | standalone mode and 2d mode." visual inspection confirms dust build up on charger cards and on the fans.It was installed in system.The system initialized.Motion, generator, communication and charging readied.2d and 3d images were successful.Dash software confirm each node charging as expected.The component was returned to the manufacturer for analysis.Analysis found that unable to confirm reported complaint, "standalone mode and 2d mode." verified both fuses in the power tray tested good.Install power tray into test system.The system powered on, booted and readied several times successfully.The system functioned as expected.Multiple 2d and 3d imaging were taken and successful.No functional problem found while under test.The component was returned to the manufacturer for analysis.Analysis found that unable to confirm reported complaint, "standalone mode and 2d mode." power conversion enclosure failed bench testing.Transistors q28 and q14 failed, both transistors are shorted.The component was returned to the manufacturer for analysis.Analysis found that not a software issue.Complaint data analysis found the event is due to a hardware issue as per complaint data- replaced power enclosure, power tray and charger enclosure.Tray and power tray were old style and needed to be updated.Software functioning as designed." continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: m021083c001, version 4.2.1: -, product id: bi71000171, serial/lot #: (b)(6), product id:bi71000175, serial/lot #: (b)(6), product id: bi71000195r, product id: bi71000176, serial/lot #:(b)(6) , product id: bi71000195, serial/lot #:(b)(6) , product id: :bi71000167, serial/lot #: (b)(6), medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the system was toggling back and forth between standalone and 2d mode.No further case details provided no patient was present at the time of event.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (BOXBOROUGH); 200 beaver brook rd; boxborough MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (BOXBOROUGH); 200 beaver brook rd; boxborough MA 01460
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 25163999
• Report Number: 3004785967-2026-00237
• Device Sequence Number: 15605008
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: (01)00643169639683(11)170901
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K200074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: 04/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Sex: Unknown