BEUDAMED
    FDA Adverse Event Summary report: N

    VIKING

    MDR report key: 1951034 · Received December 29, 2010

    Report

    Report Number
    1951034
    Date Received
    December 29, 2010
    Date of Event
    September 10, 2010
    Report Date
    December 29, 2010
    Manufacturer
    CAREFUSION (NICOLET)
    Product Code
    GWQ
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN PERFORMING A STANDARD ELECTROMYOGRAPHIC STUDY (EMG), 60 CYCLE INTERFERENCE WILL OFTEN BE SO SIGNIFICANT THAT A VALID STUDY CANNOT BE COMPLETED. EQUIPMENT DOES HAVE 60 HZ FILTERING, BUT PHYSICIANS DO NOT WANT TO DELETE THE INFORMATION IN THIS RANGE. THIS HAS OCCURRED FREQUENTLY SINCE MAY, 2008 WHEN THE BUILDING WAS BUILT. THE NATURE OF THE INTERFERENCE HAS BEEN DETERMINED TO BE RADIANT AND ATTRIBUTABLE TO THE BUILDING'S ELECTRICAL SYSTEMS: LIGHTING AND POWER DISTRIBUTION TO OTHER NEIGHBORING SERVICES.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE DEVICE WAS AFFECTED BY 60 CYCLE INTERFERENCE.====================== MANUFACTURER RESPONSE FOR EMG/EEG, VIKING======================THE SOURCE OF THE PROBLEM IS OUTSIDE AT THE EQUIPMENT. THEY RECOMMENDED LINE FILTERS AND SHIELDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIKING ELECTROENCEPHALOGRAPH GWQ CAREFUSION (NICOLET) VARIOUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 *