BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KI

    MDR report key: 24382098 · Received February 18, 2026

    Report

    Report Number
    3005905321-2026-00004
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    November 24, 2024
    Report Date
    February 9, 2026
    Manufacturer
    KI MOBILITY, LLC
    Product Code
    IOR
    UDI-DI
    00850013379033
    PMA / PMN Number
    K062660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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 AND IT WAS DETERMINED THAT THE CUSTOMER MODIFIED THE WHEELLOCK HARDWARE. THE USER MANUAL STATES THE PROPER MAINTENANCE AND SCHEDULE FOR HARDWARE.

    Description of Event or Problem · 0

    WHEEL LOCK DISENGAGED DURING PATIENT TRANSFER FROM CHAIR TO BED BECAUSE ONE OF THE WHEEL LOCK BOLTS WORKED ITS WAY OUT. BRAKE BOLT WORKED ITS WAY OUT WHILE HUSBAND WAS TRYING TO MOVE CLIENT FROM CHAIR TO BED. HUSBAND WENT TO SEAT PATIENT IN CHAIR TO GET A BETTER HOLD THEN WHEEL LOCK DISENGAGED AND CHAIR ROLLED AWAY. BOTH PATIENT AND HUSBAND FELL TO FLOOR. PATIENT COMPLAINED OF DISCOMFORT IN LEGS. END USER WAS TAKEN TO GET AN MRI WHERE THEY DISCOVERED HER LEG WAS BROKEN. END USER DID NOT COMPLAIN OF ANY PAIN/INJURY. ON 11/25 USER WENT TO PT APPOINTMENT, IT WAS SUGGUESTED THAT USER GET X-RAYS, AND THAT SHOWED BOTH LEGS TO BE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442915 KI CATALYST 5VX IOR KI MOBILITY, LLC CATALYST 5VX 00850013379033

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention