BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXON ECLIPSE CONTROLLER

    MDR report key: 2974118 · Received February 19, 2013

    Report

    Report Number
    1045254-2013-00120
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Report Date
    November 27, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    GWF
    PMA / PMN Number
    K061639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STIM BOARD FAILED THE STIMULATION TESTS AND WAS REMOVED/REPLACE. IN ADDITION, UNRELATED TO THE STIM BOARD FAILURE, THE CONNECTOR BOARD PANEL WAS REPLACED DUE TO BROKEN EMG SPEAKER PINS. THE MANUFACTURING DATE IS UNOBTAINABLE. RECORDS PRIOR TO (B)(4) 2011, REMAIN WITH THE ORIGINAL DEVICE MANUFACTURER. THE NIM-ECLIPSE SYSTEM NEUROVASCULAR WORKSTATION IS INTENDED FOR USE TO MONITOR SENSORY AND MOTOR PATHWAYS. IF THE SYSTEM FAILS TO PERFORM AS INTENDED, (ESPECIALLY TO EFFECT OR DEFECT ELECTROMYOGRAPHIC (EMG) ACTIVITY) IT PRESENTS THE POTENTIAL FOR TEMPORARY OR PERMANENT DAMAGE TO THE NERVE THAT IS PRESENT. THE ECLC ECLIPSE SYSTEM CONTROLLER PROVIDES HIGH SPEED DIGITAL DATA PROCESSING, STIMULATION GENERATION AND AUDIO PROCESSING OF EMG ACTIVITY AND ALSO SUPPLIES SWITCHED AC POWER TO THE COMPUTER. THE CONTROLLER CONNECTS TO THE COMPUTER VIA THE HIGH SPEED (B)(4) INTERFACE. WHEN INFORMATION SUGGESTS THAT THE NIM ECLIPSE EQUIPMENT HAD THE POTENTIAL TO NOT STIMULATE TO AFFECT ELECTROMYOGRAPHY (EMG), OR TO DETECT EMG, IT IS ASSUMED THAT THE FAILURE WAS DEVICE-RELATED AND MAY HAVE GONE UNDETECTED. IN THIS CASE, THERE IS NO INFORMATION TO SUGGEST AN EVENT COULD NOT BE INTERPRETED FALSELY - THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF FIELD OBSERVATION. THEREFORE, WITHOUT INFORMATION TO REASONABLY SUGGEST SERIOUS INJURY, OR THAT MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THE MANUFACTURER HAS REFINED THE CRITERIA FOR MAKING MDR DECISIONS. UPON A RETROSPECTIVE REVIEW, THE FOLLOWING EVENT IS NOW BELIEVED TO BE REPORTABLE: A CUSTOMER RETURNED AN ECLIPSE CONTROLLER - THE COMPLAINT IS UNKNOWN, UNIT RECEIVED WITHOUT ANY INFORMATION. THERE WAS NO SUGGESTION OF PATIENT INJURY OR INVOLVEMENT. TESTING/REPAIR FOUND A FAILED STIMULATION BOARD, WHICH HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY (LOSS OF STIMULATION DURING USE LEADING TO A FALSE NEGATIVE) - AS A SUDDEN FAILURE IS NOT CONSISTENTLY ACCOMPANIED BY WARNING/ERROR MESSAGES DURING A PROCEDURE. AT THIS TIME WE ARE UNABLE TO CONFIRM WHETHER THE CUSTOMER RECEIVED ANY ERROR MESSAGES OR ALERTS OF THE FAULT. THIS REPORTED EVENT HAS NO REFERENCE TO AN ALARM OR WARNING, THEREFORE, IT MUST BE ASSUMED THAT AN ALARM OR WARNING WENT UNDETECTED OR DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72656 AXON ECLIPSE CONTROLLER GWF - STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF XOMED MFG JACKSONVILLE ECLC NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1