BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3243365 · Received July 23, 2013

    Report

    Report Number
    3004493922-2013-01588
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 5, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    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

    IT WAS REPORTED THE FRAME OF THE M41RSOLID16R POWERED WHEELCHAIR HAS A BROKEN WELD AT THE POINT THE SEAT POSTED ATTACHES TO THE BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343461 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41RSOLID16R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other