BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4843837 · Received June 15, 2015

    Report

    Report Number
    1525712-2015-03413
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Report Date
    May 21, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    DEALER ADVISED JOYSTICK SHOWING DRIVE LOCKOUT AND WHEN PUT INTO SEATING AUTOMATICALLY WENT BACK TO DRIVE. DEALER ADVISED ENDUSER STATED CHAIR DRIVES BY ITSELF. DEALER ADVISED CHAIR CURRENTLY SHOWING DRIVE LOCKOUT CAUSING CHAIR NOT TO DRIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389159 TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other