BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3222378 · Received July 12, 2013

    Report

    Report Number
    3004493922-2013-01480
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 20, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE WHEEL ON THE M41SR20R POWERED WHEELCHAIR IS LOCKED. AS A RESULT, THE PATIENT IS ONLY ABLE TO DRIVE IN CIRCLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321811 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SR20R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other