BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-ECLIPSE NEUROLOGICAL WORKSTATION

    MDR report key: 2097267 · Received May 10, 2011

    Report

    Report Number
    2434986-2011-00001
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 10, 2011
    Manufacturer
    AXON SYSTEMS, INC.
    Product Code
    GWF
    PMA / PMN Number
    K050798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER LISTED NIM-ECLIPSE SYSTEM CONTROLLER AS A DEVICE RESPONSIBLE FOR THE EVENT. SINCE NIM-ECLIPSE CONTAINS SEVERAL COMPONENTS, IT WAS DECIDED TO TEST SURGEON DIRECTED PATIENT UNIT 945OPM660 (B)(4) IN COMBINATION WITH NIM-ECLIPSE SYSTEM CONTROLLER 945ECLC (B)(4). THE RESULTS OF ELECTRICAL AND FUNCTIONAL TESTING PROVIDED EVIDENCE THAT BOTH UNITS WORKED ACCORDING TO SPECIFICATIONS. ANALYSIS OF PATIENT DATA (EVENT OF (B)(6) 2011) CONFIRMED PROPER OPERATION OF NIM-ECLIPSE SYSTEM DURING THE EVENT. ON (B)(6) 2011, HOSPITAL ASKED NIHON KOHDEN FOR ASSISTANCE IN SOLVING INTERFERENCE ISSUE. IT WOULD APPEAR THAT THE EVENT WAS A RESULT OF MALFUNCTION OF THE EKG MONITOR FAILING TO PROPERLY FILTER EXTERNAL ELECTRICAL STIMULUS SIGNAL GENERATED BY THE NIM-ECLIPSE SYSTEM. A SEPARATE MDR REPORTING THE SECOND EVENT OF (B)(6) 2011 WILL BE FILED IN DUE TIME.

    Description of Event or Problem · 1

    ON (B)(4) 2011 AXON SYSTEMS, INC. LEARNED THAT IN A LUMBAR FUSION NIM CASE, WHEN THE NIM-ECLIPSE SYSTEM CONTROLLER (B)(4) WAS RUNNING IN SURGEON DIRECTED FORMAT AND SET ON NERVE PROXIMITY MODE, THE EKG MONITOR INDICATED THAT PATIENT WENT INTO VENTRICULAR TACHYCARDIA. WHEN THE NIM-ECLIPSE SYSTEM WAS CHANGED TO EMG MODE, VENTRICULAR TACHYCARDIA INDICATION ON THE EKG MONITOR STOPPED. THIS OCCURRED WITHOUT NIM INSTRUMENTS CONNECTED TO HEAD BOX. THE L-2 S-1 FUSION MUSCLE MONTAGE WAS USED WITH THE (B)(4) ELECTRODE KIT, AND THE TOF ELECTRODES WERE PLACED ON THE LEFT LATERAL POPLITEAL FOSSA. FOLLOWING THIS IMMEDIATE EVENT, THE SURGEON CHANGED OPERATIVE PLANS, CANCELLED INSTRUMENTATION, COMPLETED A DECOMPRESSION AND CLOSED. ON (B)(4) 2011, AXON SYSTEMS, INC. LEARNED THAT THE SAME CIRCUMSTANCES AND RESULTS AS REPORTED PREVIOUSLY OCCURRED DURING SURGERY WITH ALARMS ON THE ANESTHESIA MONITOR. ANESTHESIOLOGIST NOTED THE CHANGES IN THE EKG WAVEFORM AND RECOGNIZED IT AS INTERFERENCE BECAUSE PATIENT'S HEART RATE REMAINED UNCHANGED. IN BOTH CASES A (B)(4) BEDSIDE MONITOR, MODEL BSM-4101A, (B)(4) WAS USED. THIS EVENT LISTED AS A REFERENCE IS A SUBJECT OF ANOTHER MDR THAT WILL BE FILED IN DUE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIM-ECLIPSE NEUROLOGICAL WORKSTATION NIM-ECLIPSE SYSTEM GWF AXON SYSTEMS, INC. 945OPM660

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR