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	Radiation Output Problem (4026); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: kit svc o2 bi71000469 tank kit kit svc o2 bi71000542 oil and washer kit svc bi71000273 slides door cable svc o2 bi71000576r starter upgd kit rfb svc o2 bi71000230r pcba gnrtr bstr rfb kit svc bi71000416 cblasy gantry cbl chn h3) onsite functional and visual examination was performed by a manufacturer representative.After diagnosis hv tank and cable chain were deemed bad.They were replace and the machine was up and running.Replaced door cable guides while inside of the gantry.The system passed a system checkout and was returned to an operational condition.B01 c02 d02 apply.H3) no parts have been returned for analysis.B17 c20 d15 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 information regarding an imaging system being used in an unknown procedure.It was reported that while in procedure, the system would begin to perform a 3d spin, but will abort the scan.The site attempted to switch from the handswitch to the foot pedal as well as restarting the software.There was no error message present.They powered off the system and removed from wall power for 3 minutes.After power the system on the issue reoccurred.Medtronic imaging was aborted.There was a delay of less than one hour and no reported impact to patient outcome.
Additional Manufacturer Narrative
H3/h6 - evaluation of the returned tank bi71000469 lot# t181009 rev.E found a crack on the anode catheter, however, the component passed bench testing.Codes b01, c02, d02 apply.Evaluation of the returned starter board bi71000576r lot# s2239iqr rev.C found no failure.Codes b01, c19, d14 apply.Evaluation of the returned gantry chain assembly bi71000416 lot# 190103811 rev.G found a cut in the cable jacket, however the component passed bench testing.Codes b01, c07, d02 apply.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.

• 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
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19559147
• Report Number: 3004785967-2024-00362
• Device Sequence Number: 4812061
• Product Code: OWB
• UDI-Device Identifier: 00763000068066
• UDI-Public: 00763000068066
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 07/20/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Unknown