BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 20138488 · Received September 4, 2024

    Report

    Report Number
    3004785967-2024-00535
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 21, 2024
    Report Date
    September 4, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    UDI-DI
    00643169639683
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE SYSTEM WAS SERVICED IN THE FIELD BY A MEDTRONIC REPRESENTATIVE. THE REP TESTED THE SYSTEM, RESEATED AND ADJUSTED POWER SUPPLY 1 (PS1) POWER SUPPLY. THE SYSTEM WORKED WITHOUT ERRORS. CODES B01, C07, AND D02 ARE APPLICABLE. A090501: RADIATION DISABLED A1102: ERROR MESSAGES. 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 DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT AFTER BOOTING THE SYSTEM, IT WENT FROM BEING READY TO SHOW RADIATION DISABLED. TROUBLESHOOTING WAS PERFORMED. THE SYSTEM WAS DOCKED, SO THE SITE UNDOCKED IT. AFTER REBOOTING IT AGAIN, IT REMAINED IN A READY STATE. UPON CHECKING LOGS, THE TWO ERRORS THAT DAY WERE "GENERATOR INTERFACE STATUS EVENT" AND "GANTRY WDT EXPIRED." THIS WAS FIRST OBSERVED BEFORE THE O2 WAS NEEDED FOR THE CASE, SO THERE WAS NO DELAY. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833614 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000 00643169639683

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female