BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECG-9020K-V

    MDR report key: 4386016 · Received December 24, 2014

    Report

    Report Number
    2080783-2014-00134
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    February 8, 2012
    Report Date
    February 8, 2012
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT UPON PLUGGING THE ECG-9020K-V IN FOR CHARGE, THERE WAS A SPARK WHICH LED TO A SMALL FIRE ON/IN THE UNIT. THE PLUG IS DAMAGED. MFR REF #8030229-2014-00134.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850419 ECG-9020K-V ELECTROENCEPHALOGRAPH GWQ NIHON KOHDEN CORPORATION ECG-9020K-V

    Patients

    Seq Age Sex Outcome Treatment
    1 NI