BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3011794 · Received March 19, 2013

    Report

    Report Number
    1525712-2013-02080
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE DEALER REPORTED THAT THE END USER WAS OUTSIDE WITH HIS FDX-MCG CUSTOM POWER WHEELCHAIR WHEN HE TRIED TO LOGOFF THE JOYSTICK AND IT FROZE IN DRIVE MODE, AND IT WAS ALLEGEDLY VERY WARM TO THE TOUCH. UPON DEALER'S INSPECTION IT WAS FOUND THAT THE CASE MELTED FROM THE INSIDE OUT. ADDITIONALLY, IT WAS REPORTED, THAT THE END USER WAS STRANDED OUTSIDE FOR ABOUT AN HOUR. SHOULD WE RECEIVE ADDITIONAL INFORMATION, THIS FILE WILL BE REVISED, AND PERTINENT SUPPLEMENTAL REPORT WILL BE SUBMITTED. THERE WAS NO INJURY REPORTED.

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE END USER WAS OUTSIDE WITH HIS FDX-MCG CUSTOM POWER WHEELCHAIR WHEN HE TRIED TO LOG OFF THE JOYSTICK AND IT FROZE IN DRIVE MODE, AND IT WAS ALLEGEDLY VERY WARM TO THE TOUCH. UPON DEALER'S INSPECTION IT WAS FOUND THAT THE CASE MELTED FROM THE INSIDE OUT. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114266 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET FDX-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 60 Other