BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBROSCAN

    MDR report key: 24291612 · Received February 9, 2026

    Report

    Report Number
    3010258456-2026-00001
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 10, 2026
    Report Date
    February 9, 2026
    Manufacturer
    ECHOSENS
    Product Code
    IYO
    UDI-DI
    03662264001185
    PMA / PMN Number
    K223902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BETWEEN TWO EXAMINATIONS. STAFF MEMBERS REPORTED SPARKS AND A BURNING SMELL. THE DEVICE WAS IMMEDIATELY REMOVED FROM THE ROOM AND TAKEN TOWARD AN OPEN AREA. WHILE IT WAS BEING MOVED, THE MACHINE CAUGHT FIRE. THE FIRE SELF-EXTINGUISHED WITH IN A FEW SECONDS. NO HARM OCCURED TO ANY PERSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355891 FIBROSCAN ULTRASONIC PULSED ECHO IMAGING SYSTEM IYO ECHOSENS 530 COMPACT 03662264001185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown