BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECG-9020K-V

    MDR report key: 4385919 · Received December 24, 2014

    Report

    Report Number
    8030229-2014-00134
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    GWQ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS A VETERINARY USE-ONLY INSTRUMENT. THIS REPORT WAS SUBMITTED BECAUSE THE DEVICE IS SIMILAR TO FDA CLEARED HUMAN USE DEVICES, AND IF THIS FAILURE WERE TO OCCUR IN ONE OF THOSE THERE WOULD BE A LIKELIHOOD THAT IT COULD CAUSE OR CONTRIBUTE TO HARM. EXAMINATION OF THE UNIT SHOWED EVIDENCE OF FLUID INTRUSION AND THE POWER SUPPLY WAS DAMAGED. UNIT WAS REPAIRED AND RETURNED TO CUSTOMER. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF ANY PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IMP REF #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850464 ECG-9020K-V ELECTROENCEPHALOGRAPH GWQ NIHON KOHDEN CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1