BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2863727 · Received December 10, 2012

    Report

    Report Number
    1525712-2012-02798
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    December 7, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    CONSUMER STATED THAT THE RIGHT ARMREST ON A FDX POWER CHAIR HAS BROKEN AT THE PIVOT POINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other