BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEELCHAIR COMPONENTS

    MDR report key: 3490189 · Received November 26, 2013

    Report

    Report Number
    1525712-2013-09378
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Report Date
    November 13, 2013
    Manufacturer
    UNKNOWN
    Product Code
    KNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES ELR'S FREEZING UP ON MULTIPLE OCCASIONS AND NOT LOWERING. THIS HAS HAPPENED ON MULTIPLE OCCASIONS TO DIFFERENT PAIRS OF ELR'S. THIS HAS BEEN HAPPENING FOR A SIX MONTH PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617197 WHEELCHAIR COMPONENTS 890.3920 KNN UNKNOWN T94HC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other