BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3163436 · Received June 11, 2013

    Report

    Report Number
    1525712-2013-04529
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 14, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE TILT LOCKING GAS CYLINDER MALFUNCTIONING ON THE SPT MANUAL WHEELCHAIR. THIS EVENT COULD CAUSE THE TILT TO FALL BACK OR CAUSE END USER TO BECOME STRANDED IN THE TILT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264263 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SPT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other