BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR OPVSU SI NPS

    MDR report key: 23351573 · Received October 21, 2025

    Report

    Report Number
    1518293-2025-00017
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Report Date
    October 21, 2025
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    UDI-DI
    10746190002901
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: A COMPLAINT WAS RECEIVED ON AN OPTIVANTAGE INJECTOR 849001 SERIAL NUMBER (B)(6) ALLEGING TWO SEPARATE OCCASIONS WHERE THE OPERATOR RECEIVED AN ELECTRIC SHOCK WHEN THEY HAD BRUSHED PAST THE PLASTIC HOUSING OF THE CONSOLE. THERE WERE NO REPORTED INJURIES, BUT ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE OPERATOR CLAIMED TO HAVE PAIN IN THEIR HAND FOR THE REMAINDER OF THE DAY. A SERVICE ENGINEER WENT ON SITE, CHECKED THE INJECTOR FOR EARTH BONDING, INSULATION, AND LEAKAGE CURRENT, WITH NO PROBLEM FOUND. SERVICE SUSPECTS THIS WAS A STATIC DISCHARGE AS IT COULD NOT BE DUPLICATED. POTENTIAL CAUSES OF THIS STATIC DISCHARGE COULD BE THE HUMIDITY LEVELS IN THE FACILITY, WHICH WERE NOT REPORTED. LOWER HUMIDITY CAN LEAD TO STATIC BUILDUP AND CONTACT WITH THE PLASTIC HOUSING OF THE INJECTOR CAN LEAD TO THE DISCHARGE. A REVIEW OF GUERBET'S COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY: NO INJURY TO THE PATIENT/USER REPORTED IMDRF CODES: B01; C19; D15. ROOT / PROBABLE CAUSE CODE: UNKNOWN. ROOT / PROBABLE CAUSE SUMMARY: REFER TO INVESTIGATION SUMMARY. NO ADDITIONAL CAPA REQUIRED AT THIS TIME. GUERBET QUALITY WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. THESE TRENDS AND ISSUES ARE REPORTED ON DURING QUALITY METRICS REVIEW AND DURING THE MANAGEMENT REVIEWS TO CONSIDER INPUT FOR ADDITIONAL CORRECTIVE ACTION. DISPOSITION SUMMARY: UNIT REMAINED IN SERVICE.

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN (B)(6), AUSTRALIA ON 26 SEPTEMBER 2025. CUSTOMER REPORTED AN INCIDENT INVOLVING A RADIOGRAPHER RECEIVING AN ELECTRIC SHOCK FROM THE OPTIVANTAGE CT INJECTOR CONSOLE. REPORTER CONFIRMED THAT IN THE DAY'S PRIOR, THERE WERE TWO SEPARATE OCCASIONS WHERE A RADIOGRAPHER HAD RECEIVED AN ELECTRIC SHOCK WHEN THEY HAD BRUSHED PAST THE PLASTIC HOUSING OF THE CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678995 INJECTOR OPVSU SI NPS INJECTOR OPVSU SI NPS IZQ LIEBEL-FLARSHEIM 849001 10746190002901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown