BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3140792 · Received May 31, 2013

    Report

    Report Number
    1525712-2013-04278
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Report Date
    May 6, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A CROSSFIRE T6 (CRF) MANUAL WHEELCHAIR HAVING BAD BEARINGS AND MISSING SPRINGS. THIS EVENT COULD CAUSE INSTABILITY WITH THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242318 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET CROSSFIRE T6 (CRF)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other