BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTASCAN 3D BLADDER SCANNER

    MDR report key: 22902681 · Received August 27, 2025

    Report

    Report Number
    MW5175279
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    August 21, 2025
    Report Date
    August 22, 2025
    Manufacturer
    MEDA CO., LTD.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FIRE INVOLVING PORTA SCAN 3D BLADDER SCANNER MD-6000, SERIAL NUMBER (B)(6), MANUFACTURED BY MEDIA CO LTD. THE DEVICE USES A COMMON STYLE OF CHARGER PLUG AND RECEPTACLE ALLOWING A WIDE VARIETY OF CHARGERS TO BE PLUGGED INTO IT REGARDLESS OF VOLTAGE OR AMPERAGE. THE DEVICE ALSO SEEMS TO LACK OVERCHARGE/OVERCURRENT/OVER VOLTAGE PROTECTION ON THE BATTERY CHARGING CIRCUIT. THE COMBINATION OF THESE DESIGN FLAWS ALLOWED AN INCORRECT CHARGER TO BE PLUGGED IN, OVERHEATING THE DEVICE AND RESULTING IN A FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313138 PORTASCAN 3D BLADDER SCANNER SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO MEDA CO., LTD. MD-6000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown