BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3083781 · Received April 29, 2013

    Report

    Report Number
    1525712-2013-03385
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    December 10, 2012
    Report Date
    April 3, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    END USER STATES ARM REST ARE TORE UP AND CUTTING INTO SKIN OF PATIENT I SPOKE TO MOTION CONCEPTS ACCORDING TO MOTION CHAIR LEFT OUT AS A JAZZY POWER CHAIR AND HAS A MONTION SEATING SYSTEM CONSUMER MENTIONED PREV DEALER (B)(6) TOOK CHAIR BACK AND MADE ADJUSTMENTS PUT DIFFERENT PARTS AND PIECES TO CHAIR CONSUMER IS REALLY NOT SURE WHO CHAIR BELONGS TO CONSUMER HAS CONTACTED DEALER UNIT SEATING AND HAS NOT BEEN ABLE TO RESOLVE ISSUE WITH THE ARM RESTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184079 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 Other