BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3062090 · Received April 16, 2013

    Report

    Report Number
    1525712-2013-02902
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 20, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH BAD CASTER BEARINGS ON AN UNKNOWN POWER CHAIR. THIS EVENT COULD CAUSE PRODUCT INSTABILITY AND POTENTIAL FOR THE CHAIR TO TIP OVER OR THE USER TO BECOME STRANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163620 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other