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	Noise, Audible (3273); Radiation Output Problem (4026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the system was used for 5 different spins, but on the 6th time, the unit started beeping.It was noted the battery status was full.There was no patient involvement.Additional information was received.It was found that the system would display early termination during a 3d spin.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: b i71000469, serial, lot: unknown, product id: bi71000192, serial, lot: unknown, product id: bi71000901, serial, lot: unknown, product id: bi71000194, serial, lot: unknown, product id: bi71000576, serial, lot: unknown, and product id: bi71000416, serial, lot: unknown, h3, h6) the system was serviced in the field.In the first servicing instance, no faults were found and the system performed as intended.Codes b01, c19, and d14 are applicable.H3, h6) the system was additionally serviced at a later date and multiple issues were found.It was found that the system would display early termination during 3d spin and there was damage found to the rotor tractor drive.Additionally, error 40 and 41 were found which indicated an imbalanced kilovolts (kv) and milliamperes (ma).It was also found that the tube had charring on the anode.The "oscope" indicated there was a cable chain and tank issue, also.As a result, the rotor tractor drive, tube, tank and cable chain were replaced and the system then performed as intended with applicable generator calibrations and testing.Codes b01, c02, c07, c13, and d02 are applicable.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.
Additional Manufacturer Narrative
H3) the kit svc o2 bi71000469 tank kit was replaced.It was determined that there were cracks on the device.B01 c07 d02 apply the kit svc bi71000901 tube x-ray a132 fsp, and kit svc o2 bi71000576 starter upgd kit were returned for analysis.Functional testing determined the components were functioning as designed.B01 c19 d14 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.
Additional Manufacturer Narrative
H3) cable was returned for analysis there were unable to confirm reported complaint, "constant beeping noise." candlesticks and x-ray tube cable assembly passed continuity testing.No problem found.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: 20070141
• Report Number: 3004785967-2024-00508
• Device Sequence Number: 18266795
• Product Code: OWB
• UDI-Device Identifier: 00763000068066
• UDI-Public: 00763000068066
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 11/08/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 10/25/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/25/2024; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2018
• 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