BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2970701 · Received February 20, 2013

    Report

    Report Number
    3004493922-2013-00420
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATED THAT THE ALIGNMENT OF THE BACK OF CHAIR IS OFF BY OVER AN INCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74597 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M51SEMIBLUE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other