BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2960043 · Received February 13, 2013

    Report

    Report Number
    3004493922-2013-00335
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES USER SMELLED A BURNING SMELL AND MOTOR COMPLETELY STOPPED. HE SAID IT DOES NOT MOVE, DOES NOT MAKE ANY NOISE AND HE SAID IT GAVE A 5 FLASH. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63472 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SR20R

    Patients

    Seq Age Sex Outcome Treatment
    1 59 Other