BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3923570 · Received July 9, 2014

    Report

    Report Number
    1525712-2014-03583
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 5, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    WHERE THE SEAT WIDTH ADJUSTMENT BOLT IS WELDED TO THE SEAT FRAME, THE WELD HAS COME LOOSE AND IS PULLING AWAY. THE SEAT WILL NOT STAY IN ADJUSTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399516 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSI-HD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other