BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KI

    MDR report key: 24382374 · Received February 18, 2026

    Report

    Report Number
    3005905321-2026-00005
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    November 22, 2023
    Report Date
    February 9, 2026
    Manufacturer
    KI MOBILITY, LLC
    Product Code
    IOR
    UDI-DI
    00850013379316
    PMA / PMN Number
    K062660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 PART WERE PROVIDED. COMPLAINT INVESTIGATION REPORT - RISK ANALYSIS. THE DATA SUGGESTS THE DEVICE WAS USED OUTSIDE OF INTENDED USE: THE CASTER HOUSING WAS REPORTED LOOSE UPON RECEIPT OF THE CHAIR. MULTIPLE ATTEMPTS TO TIGHTEN THE CASTER MOUNT FAILED, YET THE DEALER ALLOWED USE OF THE CHAIR. THE USER FELL FORWARD OUT OF HTE CHAIR AFTER MULTIPLE FAILED ATTEMPTS TO TIGHTEN THE BOLTS. JUSTIFICATION FOR ACCEPTANCE OF RESIDUAL RISK: ALL MATERIALS HAVE A FAILURE POINT IF SUBJECTED TO OVER-STRESSING AND MISUSE OF VARYING DEGREES, MAKING AN INHERENTLY SAFE DESIGN IMPOSSIBLE. TESING IN COMPLIANCE WITH APPLICABLE HARMONIZED STANDARDS PROVIDES A PROTECTIVE MEASURE BY DEMONSTRATING STRENGTH AND DURABILITY, THUS MINIMIZING THE RISK OF THE HAZARDOUS SITUATION OF COMPONENT FAILURE. INSTRUCTION FOR PROPER USE AND WARNING AGAINST MISUSE IN THE OWNER'S MANUAL ARE THE ONLY FURTHER ACTIONS THAT CAN BE TAKEN TO MINIMIZE RISK. RISK IS REDUCED AS FAR POSSIBLE.

    Description of Event or Problem · 0

    DEALER CLAIMS THE LEFT CASTER HOUSING IS ROTATING UNDER THE CHAIR. HAS BEEN LOOSE SINCE THEY GOT THE CHAIR, DEALER AND USER HAVE HAD TO CONSTANTLY TIGHTEN IT. END USER STATED THE LEFT CASTER MOUNT AND HOUSING ROTATED BACKWARDS UNDER THE CHAIR CAUSING THE USER TO FALL FORWARD OUT OF THE CHAIR. USER BROKE HIS ANKLE AND FOOT. HAPPENED AT THE END USER'S HOME. END USER WAS TRYING TO TRANSFER ONTO HIS STAIR LIFT WHEN THE LEFT HOUSING ROTATED UNDER HIS CHAIR WHICH MADE THE CHAIR FALL FORWARD. HE COULD HAVE FALLEN DOWN THE STAIRS BUT INSTEAD FELL ONTO HIS LEFT LEG AND FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272004 KI ROGUE ALX IOR KI MOBILITY, LLC ROGUE ALX 00850013379316

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Required Intervention