BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 19751462 · Received July 16, 2024

    Report

    Report Number
    3004785967-2024-00421
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    May 23, 2024
    Report Date
    December 9, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OWB
    UDI-DI
    00763000355555
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI-500-01145, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: M021083C001, VERSION #: 4.2.0, UBD: , UDI#: H3). NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. CODES: 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.

    Additional Manufacturer Narrative · 0

    H2) PLEASE SEE SECTION D3-4 FOR THE ADDITIONAL INFORMATION. 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING 4.3.0 RC4 3D IMAGE QUALITY TESTING ON 2871 (4030D PANEL), SOME RING, OR PARTIAL RING, ARTIFACTS WERE OBSERVED IN IMAGES OF THE CUSTOM LUMBAR SPINE PHANTOM WITH A LARGE CATPHAN OVAL ANNULUS (REPRESENTING BODY MASS INDICES OF LARGE AND EXTRA-LARGE PATIENTS). THERE WAS ALSO SIMILAR ARTIFACT IN A 20 CENTIMETERS (CM) FIELD OF VIEW (FOV) SCAN OF THE SAME PHANTOM SETUP. THE STANDARD AND EXTENDED RADIATION GAIN CALIBRATIONS WERE DONE ON THE SAME DAY, PRIOR TO THE START OF 3D IMAGE QUALITY TEST SCANS. THE ARTIFACT APPEARED MOST VISIBLY AS VERTICAL LINES IN THE SAGITTAL SLICES. THIS LOOKED SIMILAR TO THE ASIC ¿LINE ARTIFACT,¿ OR PARTIAL RING ARTIFACT, THAT IS A CHARACTERISTIC OF 40CM FOV SCAN WITH THE 4030DX PANEL. THE RING ARTIFACTS OF CONCERN WERE VISIBLE AROUND THE CENTER OF THE PHANTOM IN THE AXIAL VIEW AND WERE VISIBLE AS VERTICAL LINES IN THE SAGITTAL VIEW. THE INDICATION OF RING ARTIFACT BEGAN WITH THE SMALLER OF THE TWO CATPHAN OVAL ANNULI. RING ARTIFACT BECAME MORE VISIBLE WITH THE LARGER ANNULUS. THE CAUSE WAS BEHAVIOR OF THE 4030D DETECTOR PANEL WHEN THERE WAS SUBSTANTIAL X-RAY ATTENUATION FROM THE PHANTOM AND, ALSO, DIRECT X-RAY IRRADIATION OF THE DETECTOR. ARTIFACTS MAY OCCUR WITH THESE CONDITIONS FOR SCANS WITH AN EXTRA-LARGE PATIENT PROTOCOL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2518330 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) BI70002000 00763000355555

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown