BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAINFRAME RESPONSE 2.0

    MDR report key: 3738435 · Received April 10, 2014

    Report

    Report Number
    1045254-2014-00079
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    IKN
    PMA / PMN Number
    K024316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED ON (B)(4) 2014. THE DEVICE WAS ANALYZED ON (B)(4) 2014. THE PRODUCT ANALYSIS STATES, ¿SHAKE TEST WAS PERFORMED ON THE MAINFRAME; NO LOOSE PARTS WERE HEARD. THE INTERFACE, SIMULATOR AND PROBE WERE CONNECTED AND THE MAINFRAME TURNED ON; BOOT-UP SEQUENCE COMPLETED WITH NO ERRORS. TOUCHSCREEN RESPONDED. A MONITORING MODE WAS SELECTED USING ALL AVAILABLE CHANNELS. EACH CHANNEL WAS STIMULATED IN TURN; NORMAL AND APPROPRIATE RESPONSES WERE SEEN ON ALL CHANNELS. THE STIM SETTING WAS CHANGED USING THE PROBE; SYSTEM RESPONDED APPROPRIATELY. ELECTRODE CHECK WAS WITHIN ACCEPTABLE RANGES FOR ALL CHANNELS, STIM 1 AND 2, AND GROUND. THE UNIT WAS PLACED IN THE BURN-IN OVEN FOR 24 HOURS IN AN ATTEMPT TO DUPLICATE THE FAILURE BUT IT FUNCTIONED NORMALLY.¿ (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NIM WAS MAKING ¿CONSTANT NOISE.¿ THIS ISSUE OCCURRED APPROXIMATELY 1.5 HOURS INTO CASE (SURGERY UNKNOWN) AND RESULTED IN THE SITE CANCELLING THE CASE DUE TO TOO MUCH ARTIFACT. REPORTEDLY, "THE NIM2.0 WAS WORKING FINE FOR ABOUT AN HOUR INTO THE CASE. IT RANDOMLY STARTING BEEPING ON ALL CHANNELS AND THEN [THE USERS] NOTICE[D] THE BOX HAD MOVED FROM ITS ORIGINAL LOCATION. THEY CONFIRMED ELECTRODES WERE CONNECTED, AND WRAPPED THE BOX IN A TOWEL. THEY STILL RECEIVED RANDOM RESPONSES EVEN WHEN NOT TOUCHING THE PATIENT." THE FOLLOW-UP CONTACT WAS NOT SURE OF ANY DETAILS ABOUT THE POTENTIALLY RESCHEDULED SURGERY OR CLINICAL IMPACT, AND THE INITIAL REPORT INDICATED THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219030 MAINFRAME RESPONSE 2.0 STIMULATOR, NERVE IKN MEDTRONIC XOMED, INC. 8252001IP 48446200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other