BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLECONNECT

    MDR report key: 24168025 · Received January 23, 2026

    Report

    Report Number
    3015060244-2026-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 20, 2026
    Manufacturer
    ROM TECHNOLOGIES, INC
    Product Code
    IKK
    UDI-DI
    00860002828718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE POWER CORD WRAPPED AROUND THE PEDAL AND BROKE, EXPOSING CONDUCTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231557 PORTABLECONNECT ISOKINETIC TESTING AND EVALUATION SYSTEM IKK ROM TECHNOLOGIES, INC 10100 00860002828718

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female