BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE DEVILBISS HEALTHCARE TITAN AXS K0823 MWD

    MDR report key: 23565822 · Received November 16, 2025

    Report

    Report Number
    9616873-2025-00002
    Event Type
    Injury
    Date Received
    November 16, 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
    LA
    Reporter Occupation
    003

    Narratives

    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
    274257 DRIVE DEVILBISS HEALTHCARE TITAN AXS K0823 MWD WHEELCHAIR, POWERED, PRODUCT CODE: ITI INO WU'S TECH CO., LTD. TITANAXS-20CS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention