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); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: the main component of the system.Other relevant device(s) are: product id: bi71000176, serial/lot #: rev 5: sn (b)(4); product id: bi71000195, serial/lot #: rev.1 s/n n/a.A medtronic representative went to the site to test the equipment.Testing revealed that x ray would not initialize on pendant and there was no 400 vdc output from the power enclosure.The power enclosure was replaced and power tray was upgraded.The system passed the system checkout and was found to be fully functional.Evaluation codes that apply to this testing: (b)(4) the power tray was returned for analysis.Analysis found that both fuses in the power tray were verified and tested good.The power tray was installed into a known good system and the system functioned as expected.Multiple 2d and 3d imaging were taken and were successful.No functional problem was found.Evaluation codes that apply to this testing: (b)(4) the power enclosure (rev 5 : sn (b)(4))) was returned for analysis.Analysis confirmed the complaint.The power enclosure was installed into a known good system.The system failed to boot, the generator would not ready and x-ray was disabled.The power enclosure was faulty.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.Evaluation codes that apply to this testing: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the system was unable to initialize and the radiation will not enable.The rep rebooted the system twice.They also invalidated home because the system would not close its doors.No patient was present.Additional information was received from a company rep.It was reported that the issue of the doors not closing was resolved, but the initialization issue wasn't resolved.A system checkout was going to be performed.Additional information was received from a company rep.The rep took a look at the system and determined it needs a power enclosure module.

• 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: 12550236
• Report Number: 3004785967-2021-01160
• Device Sequence Number: 16974749
• 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: 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): 09/29/2021

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: 09/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1