BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3203305 · Received July 2, 2013

    Report

    Report Number
    1525712-2013-05293
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES THEY REPLACED BOTH MOTORS (B)(4) AND THE CUSTOMER SAYS THE CHAIR IS ROLLING BACK WHEN GOING UP RAMPS. THE DEALER HAS NOT WITNESSED THIS ISSUE AND THERE IS NO COMPLAINT OF BRAKE FAULTS COMING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300957 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other