BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 606212 · Received May 16, 2005

    Report

    Report Number
    606212
    Event Type
    Malfunction
    Date Received
    May 16, 2005
    Date of Event
    May 11, 2005
    Report Date
    May 16, 2005
    Manufacturer
    NIHON KOHDEN AMERICA INC
    Product Code
    GWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS UNDERGOING A SERIES OF EVOKED POTENTIAL TESTS. SOMATOSENSORY TESTING OF THE LEFT UPPER EXTREMITY WAS ABOUT TO BE PERFORMED. THE ELECTRODES WERE IN PLACE ON THE PATIENT AND THE ELECTRICAL STIMULUS WAS SET TO ZERO. WHEN THE STIM BUTTON WAS DEPRESSED PATIENT CRIED OUT THAT STIM WAS HURTING THEM. ANOTHER TECH REMOVED ELECTRODES FROM PATIENT AND PLACED ON SELF TO DETERMINE THE VALIDITY OF PATIENTS COMPLAINT. THE TECH ALSO EXPERIENCED INTENSE STIMULATION WHEN THE BUTTON WAS DEPRESSED. THE TESTING WAS STOPPED, AND WAS REMOVED FROM SERVICE. THE BIOMED DEPARTMENT WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * EVOKED POTENTIAL UNIT GWF NIHON KOHDEN AMERICA INC KD-012A *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR