BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3851316 · Received June 5, 2014

    Report

    Report Number
    1525712-2014-02888
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    April 22, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELEVATED LEG RESTS ON THE LEFT SIDE OF THE TDX3BASE POWER WHEEL CHAIR WERE LOWER THAN THE OTHER SIDE. BRACKET ASSEMBLY THAT HOLDS THE ELEVATED LEG RESTS WAS BROKEN AT THE WELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329181 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDX3BASE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other