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	Application Program Problem (2880); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: a medtronic representative went to the site to test the equipment.Testing revealed that this was not a system booting please wait error.System initializing error was the issue.Stand a lone board resistor blew.Replaced stand alone board.Did a medtronic check out test.All test passed.B01, c02, d02 codes are applicable.H3, h6: the pcba genrtr isol was returned to the manufacturer for analysis.Analysis found that confirmed reported complaint.Visual inspections shown components r19, r20, r21 and c13 were electrically over stressed.B01, c02, d02 codes are applicable.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000225, serial/lot #: s1719euq rev.R.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received the information regarding an imaging system being used outside of procedure.It was reported that the ias(imaging acquisition system) was stuck in initialization.This was a second occurrence of the system experiencing system booting please wait error issue.Troubleshooting: manufacturing representative performed the following: turned ias(imaging acquisition system) and mvs(mobile viewing station) off.Rebooted both mvs(mobile viewing station) and ias(imaging acquisition system).Turned off both systems and unplugged umbilical cord.Unplugged mvs(mobile viewing station) from wall.Turned ias(imaging acquisition system) on without being connect to mvs(mobile viewing station).Plugged ias(imaging acquisition system) into mvs(mobile viewing station) while powered on.Issue persisted after each step of troubleshooting.No patient present.Additional information stating that another case was system booting error and this was a stuck in initialization error and they were not related.This was not a second occurrence.

• 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: 24673653
• Report Number: 3004785967-2026-00162
• Device Sequence Number: 16042392
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: (01)00643169639683(11)180212
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/24/2026

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
• Device Lot Number: -
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2018
• 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
• Patient Sex: Unknown