BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KONICA MINOLTA

    MDR report key: 16618332 · Received March 27, 2023

    Report

    Report Number
    9617251-2023-00002
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Report Date
    March 26, 2023
    Manufacturer
    SEDECAL SA
    Product Code
    IZO
    UDI-DI
    08436046001374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    TECHNOLOGIST STATED THEY WERE IMAGING A PATIENT THOUGHT THEY HEARD A POP AFTER THE LAST IMAGE. THEY LET THE PATIENT GO AND LEFT THE ROOM THEY CAME BACK IN AND SMELLED SMOKE THAN THEY SAW A FLAME COME OUT OF THE GENERATOR THEY KILLED THE POWER AND EVACUATED THE BUILDING AND CALLED THE FIRE DEPARTMENT THE FIRE DEPARTMENT CUT ALL THE CABLES TO THE GENERATOR AND MOVED THE GENERATOR OUT OF THE BUILDING. NO INJURY WAS REPORTED. THE GENERATOR CAUGHT FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934602 KONICA MINOLTA GENERATOR, HIGH-VOLTAGE, X-RAY, DIAGNOSTIC IZO SEDECAL SA SHFR-500 08436046001374

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown