BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4173130 · Received October 15, 2014

    Report

    Report Number
    1525712-2014-06982
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 25, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER KEEPS BREAKING THE ARM PIVOT SOCKET. DEALER STATES THIS IS ABOUT THE 15TH TIME HE HAS REPLACED THIS ON THE CHAIR OVER THE LAST 5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654167 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET R51

    Patients

    Seq Age Sex Outcome Treatment
    1 Other