BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIKING

    MDR report key: 2484931 · Received March 6, 2012

    Report

    Report Number
    3008289288-2011-00003
    Event Type
    Other
    Date Received
    March 6, 2012
    Date of Event
    September 10, 2010
    Report Date
    March 9, 2011
    Manufacturer
    CAREFUSION 209 INC.
    Product Code
    IKN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION FIELD SERVICE ENGINEER WENT ON SITE IN (B)(4) 2008 AND OBSERVED THE FOLLOWING: IN NEW BUILDING, FOUND NO DEDICATED POWER LINES, GFI OUTLETS WERE TIED INTO THE SAME CIRCUIT OF THE VIKING MACHINES. WIRELESS ACCESS POINT OUTSIDE ROOM G5. ROOM LIGHTS AND BIOSONE ARE ELECTRICALLY NOISY, ALSO RECOMMENDED AGAINST ANY UNSHIELDED POWER DEVICES (RADIOS AND LIGHTS). RECOMMENDED SEPARATE DEDICATED CIRCUIT FOR ALL EMG MACHINES. RECOMMENDED AGAINST POWER STRIPS. VERIFIED ALL SYSTEMS AND THEY HAD GREAT BASELINE, NO NOISE WAS REPRODUCED UNLESS USING BAD AMPLIFIERS. CAREFUSION FIELD SERVICES ENGINEER AND SALES REP ARE VISITING THE CUSTOMER SITE ON (B)(4), 2011 TO DISCUSS THIS ISSUE. SENDING RESPONSES TO QUESTIONS ASKED BY FDA TO (B)(4).

    Description of Event or Problem · 1

    WHEN CUSTOMER IS PERFORMING A STANDARD ELECTROMYOGRAPHY STUDY (EMG), 60 CYCLE INTERFERENCE WILL OFTEN BE SO SIGNIFICANT THAT A VALID STUDY CANNOT BE COMPLETED. EQUIPMENT DOES HAVE 60HZ FILTERING, BUT PHYSICIANS DO NOT WANT TO DELETE THE INFO IN THIS RANGE. THIS HAS OCCURRED FREQUENTLY SINCE (B)(6) 2008 WHEN THE NEW BUILDING WAS BUILT. THE NATURE OF THE INTERFERENCE HAS BEEN DETERMINED TO BE RADIANT AND ATTRIBUTED TO THE BUILDING'S ELECTRICAL SYSTEMS: LIGHTING AND POWER DISTRIBUTION TO OTHER NEIGHBORING SERVICES. (B)(4). CAREFUSION DID NOT REPORT THIS EVENT BECAUSE THERE WAS NO DEATH OR SERIOUS INJURY OR THAT THE EQUIPMENT MALFUNCTIONED AND WOULD CAUSE DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIKING VIKING IKN CAREFUSION 209 INC. VARIOUS N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other