BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3130476 · Received May 24, 2013

    Report

    Report Number
    1525712-2013-04175
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 1, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE FOOTREST ON THE POWER CHAIR WAS BREAKING IN HALF. THIS ISSUE COULD PREVENT A USER FROM OBTAINING THE NEEDED SUPPORT FOR THE FEET CREATING THE POTENTIAL FOR THE USER TO SLIP AND FALL OUT OF THE CHAIR AND BEING INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230838 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other