BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3171344 · Received June 14, 2013

    Report

    Report Number
    1525712-2013-04703
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 21, 2013
    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

    POTENTIAL FOR INJURY ASSOCIATED WITH A BROKEN ARM ASSEMBLY ON AN M51R POWER CHAIR. THIS EVENT COULD CAUSE POSSIBLE PRODUCT INSTABILITY AND THE POTENTIAL FOR END USER TO FALL OUT OF THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271110 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other