BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3243249 · Received July 23, 2013

    Report

    Report Number
    3004493922-2013-01595
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 3, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A M41SRB POWERED WHEELCHAIR WAS STOPPING ON ITS OWN. WHEN THE CHAIR STOPPED MOVING, THE WRENCH FLASHED SEVERAL TIMES AND AFTER COMPLETING THE STALL TEST, THE VOLTAGE WENT FROM 25 TO 18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343317 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other