BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 21273803 · Received January 30, 2025

    Report

    Report Number
    3004785967-2025-00078
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    December 13, 2023
    Report Date
    January 30, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000852, UBD: UNKNOWN, UDI#: UNKNOWN PRODUCT ID: BI71000450, UBD: UNKNOWN, UDI#: UNKNOWN PRODUCT ID: BI71000163, UBD: UNKNOWN, UDI#: UNKNOWN F1908: DELAY OF LESS THAN ONE HOUR F26: NO PATIENT IMPACT G04040: GENERATOR G02027: POWE SUPPLY G02002: BATTERY G2: THIS EVENT OCCURRED IN THE GREAT BRITAIN, SEE SECTION E. H3, H6: THE SYSTEM WAS SERVICED IN THE FIELD. THE CMOS BATTERY WAS REPLACED. IT WAS FOUND THAT THE BATTERY TRAY 6 NEEDED TO BE REPLACED. CODES B01, C02, AND D02 ARE APPLICABLE. ADDITIONAL SYSTEM SERVICE WAS PERFORMED. BATTERY TRAY 6 WAS REPLACED. CODES B01, C02, 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO LET THE RADIOLOGIC TECHNOLOGIST (RT) TO PERFORM A 2D IMAGE. A LIGHT DID NOT APPEAR ON TOP OF THE MOBILE VIEW STATION (MVS.) THE MANUFACTURER REPRESENTATIVE (REP) HAD TO ASSIST BY RESTARTING THE IMAGE ACQUISITION SYSTEM (IAS) AND MVS SEVERAL TIMES FOR IT TO WORK. DURING TROUBLESHOOTING, THE ERROR LOGS INDICATED AN ERROR 38 +5V OUT OF SPECIFICATION, AND THE SYSTEM CLOCK WAS OUT OF SPECIFICATION AS WELL. THE PROBABLE CAUSE OF THE ISSUE WAS LIKELY A POWER SUPPLY (PS1) DRIFT AND LOW VOLTAGE WITH THE GENERATOR COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS.) THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. THE CASE BEING PERFORMED WAS A NAVIGATED TLIF. AFTER RESTARTING THE SYSTEM, THE SITE WAS ABLE TO COMPLETE THE PROCEDURE WITH ONLY A SMALL DELAY IN TIME AND EVERYTHING WENT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589357 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male "SEE H11...."