BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KONICA MINOLTA

    MDR report key: 16581992 · Received March 21, 2023

    Report

    Report Number
    9617251-2023-00001
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    February 10, 2023
    Report Date
    March 19, 2023
    Manufacturer
    SEDECAL SA
    Product Code
    IZO
    UDI-DI
    08436046000438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT INVOLVED: NO. NO PATIENT WAS IN ROOM WHEN TECHNOLOGIST SAW SMOKE. INJURIES: NO. TECHNOLOGIST LEFT ROOM SO NO INJURY. ISSUE: ON (B)(6) 2023 AROUND 6:19PM THE TECHNOLOGIST WAS TAKING A BREAK AND WHEN HE CAN BACK INTO THE ROOM THE GENERATOR WAS SMOKING IT TRIGGERED THE FIRE ALARM SO THE FIRE DEPARTMENT CAME AND HAD TO PUT OUT THE FIRE BY A FIRE EXTINGUISHER. THE SITE CUT ALL WIRES FROM THE GENERATOR AND REMOVED IT FROM THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7955 KONICA MINOLTA GENERATOR, HIGH-VOLTAGE, X-RAY, DIAGNOSTIC IZO SEDECAL SA SHF-835 08436046000438

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown