BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2863638 · Received December 10, 2012

    Report

    Report Number
    1525712-2012-02800
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    December 7, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES UNIT IS NOT COMING BACK TO CENTER AND IT IS STICKING. ADDITONAL INFORMATION INCLUDES THIS IS A RIM JOY STICK, THE PATIENT CONTROLS THE CHAIR BY PUSHING HIS HEAD BACK AGAINST THE JOY STICK. TO MAKE THE CHAIR GO FORWARD HE PUSHES BACK ON THE JOY STICK, TO STOP HE PULLS HIS HEAD FORWARD AWAY FROM THE JOY STICK. THE JOY STICK IS NOT SPRINGING BACK TO THE STOP POSITION AND THE CHAIR ISN'T STOPPING. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 07CE001408

    Patients

    Seq Age Sex Outcome Treatment
    1 48 Other