BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE DEVILBISS HEALTHCARE TITAN AXS K0823 MWD

    MDR report key: 23601586 · Received November 20, 2025

    Report

    Report Number
    9616873-2025-00003
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 22, 2025
    Manufacturer
    WU'S TECH CO., LTD.
    Product Code
    INO
    PMA / PMN Number
    K050010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    3500A REPORT: THE SERVICE PROVIDER STATED THAT THE WHEELCHAIR "GOT STUCK" WHEN THE END USER WAS GOING DOWNHILL. THE END USER ATTEMPTED TO MOVE THE WHEELCHAIR FORWARD, BUT IT "LURCHED FORWARD," CAUSING THE END USER TO FALL OUT. FOLLOW-UP EMAIL: ACCORDING TO THE SUPPLIER, THE EQUIPMENT HAS BEEN REPAIRED. THE REPAIR INCLUDED REPLACING TWO CASTERS AND AN UPPER CONTROLLER. I DON'T UNDERSTAND THE CONNECTION BETWEEN THE REPLACED PARTS AND THE INCIDENT.

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A MOTORIZED CHAIR BY THE PROVIDER WHO STATED THAT WHEN THE END USER WAS GOING DOWN A RAMP, THE CHAIR "LOCKED UP." THE END USER TRIED TO MAKE THE CHAIR MOVE FORWARD AND THE CHAIR "TOOK OFF" CAUSING THE END USER TO FALL OFF THE CHAIR. THE END USER BROKE HER LEG THAT REQUIRED SURGERY. THE PROVIDER CONFIRMED THAT THE END USER HAD THEIR SEATBELT ON AT TIME OF THE INCIDENT. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262747 DRIVE DEVILBISS HEALTHCARE TITAN AXS K0823 MWD WHEELCHAIR, POWERED INO WU'S TECH CO., LTD. TITANAXS-20CS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention