BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOHON KOHDEN, EEG

    MDR report key: 58818 · Received December 23, 1996

    Report

    Report Number
    58818
    Event Type
    Malfunction
    Date Received
    December 23, 1996
    Date of Event
    December 20, 1996
    Report Date
    December 20, 1996
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Product Code
    GWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS SCHEDULED FOR OUTPATIENT EEG. SEDATION HAD BEEN GIVEN. PT WAS ATTACHED TO MACHINE. TECH ATTEMPTED TO CALIBRATE MACHINE. UNABLE TO CALIBRATE. UNABLE TO DO EEG. WILL HAVE TO RESCHEDULE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOHON KOHDEN, EEG EEG MACHINE GWS NIHON KOHDEN AMERICA, INC. 4317B *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 MO Other