BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX

    MDR report key: 4509940 · Received February 12, 2015

    Report

    Report Number
    1031452-2015-07133
    Event Type
    Malfunction
    Date Received
    February 12, 2015
    Date of Event
    January 30, 2015
    Report Date
    February 5, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CHAIR TDXSP WHEN POWERING UP DURING NEUTRAL TESTING MODE IF JOYSTICK IS TOUCHED CHAIR TAKES OFF . CHAIR HAS ASL MONSTER JOYSTICK AND SIDE EGG SWITCHES THAT WERE ATTACHED TO HOUSING AFTER DELIVERY WARRANTY SEAL WAS BROKEN ON JSK. NO INJURY OR DAMAGE USER GOT STARTLED. THIS EVENT HAPPENED ONCE FOR THE USER AND ONCE FOR THE DEALER WITHIN A DAY OUR DEALER HAS CHAIR AND CAN NOT DUPLICATE THE PROBLEM AFTER MULTIPLE HOURS OF TESTING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103890 TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX WHEELCHAIR, POWERED ITI INVACARE FLORIDA OPERATIONS TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other