BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 16294218 · Received February 3, 2023

    Report

    Report Number
    2438477-2023-00006
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Report Date
    February 2, 2023
    Manufacturer
    WU'S TECH CO., LTD.
    Product Code
    ITI
    UDI-DI
    00822383933924
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A POWERCHAIR BY AN END USER, WHO STATED THAT "WHILE DRIVING FORWARD, THE SPEED INCREASED DRASTICALLY AND THE CHAIR GOT RAMMED INTO HER HOSPITAL BED, BANGING HER LEG INTO THE METAL FRAME," CAUSING A "LARGE LUMP" STICKING OUT OF HER LEFT LEG. THE END USER WENT TO THE HOSPITAL, WHERE IT WAS DETERMINED THAT NOTHING WAS BROKEN. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943030 DRIVE POWERED WHEELCHAIR ITI WU'S TECH CO., LTD. TITAN AXS 00822383933924

    Patients

    Seq Age Sex Outcome Treatment
    1 Female