BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KI

    MDR report key: 24381745 · Received February 18, 2026

    Report

    Report Number
    3005905321-2026-00003
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    October 1, 2024
    Report Date
    February 9, 2026
    Manufacturer
    KI MOBILITY, LLC
    Product Code
    IOR
    UDI-DI
    00850013379033
    PMA / PMN Number
    K062660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RETROSPECTIVE REVIEW OF COMPLAINTS, THIS REPORT WILL BE FILED IN ABUNDANCE OF CAUTION BECAUSE RECORD WAS NOT REPORTED. NO ADDITIONAL INFORMATION OR COMMUNICATION WITH THE END USER AFTER THE INITIAL REPORT. REPLACEMENT PARTS WERE PROVIDED. RETURNED PRODUCT WAS EVALUATED WITH NO ROOT CAUSE IDENTIFIED.

    Description of Event or Problem · 0

    DEALER CLAIMS THAT THE END USER WAS TRANSFERRING OUT OF THE CHAIR AND THE ARMREST RECEIVER FELL OUT AND THE END USER FELL AND BROKE 2 RIBS. DEALER STATED THAT THEY HAD BEEN OUT 5 TIMES FOR MAINTENANCE AND TIGHTENED THE HARDWARE FOR THE ARMREST RECEIVERS. IT HAPPENED ON 10/24 AT THE END USER'S HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470456 KI CATALYST 5VX IOR KI MOBILITY, LLC CATALYST 5VX 00850013379033

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Hospitalization