BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE DEVILBISS HEALTHCARE TITAN AXS K0823 MWD

    MDR report key: 23363963 · Received October 22, 2025

    Report

    Report Number
    2438477-2025-00057
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 5, 2025
    Report Date
    November 20, 2025
    Manufacturer
    WU'S TECH (VIETNAM) CO.LTD
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S ADDRESS WAS INCORRECTLY REPORTED ON MDR 2438477-2025-00057 ON 10/22/2025. THE CORRECT MANUFACTURER'S ADDRESS IS WU'S TECH (VIETNAM)CO., LTD. NO31. VSIPII, ROAD 6, HOA PHU WARD, TDM CITY, BINH DUONG PROVINCE VM. SECTION D3 AND F14 HAVE BEEN UPDATED WITH THE CORRECT ADDRESS. THE DEVICE IS NOT RETURNING FOR EVALUATION. THE DEVICE WAS REPAIRED AND IS CURRENTLY BEING USED BY THE END USER.

    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
    2777242 DRIVE DEVILBISS HEALTHCARE TITAN AXS K0823 MWD WHEELCHAIR, POWERED ITI WU'S TECH (VIETNAM) CO.LTD TITANAXS-20CS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention