BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8253001 NIM RESPONSE 3.0

    MDR report key: 3823914 · Received May 21, 2014

    Report

    Report Number
    1045254-2014-00115
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCT: 8253200: PATIENT INTERFACE 8253200 RESPONSE 3.0 (B)(4), LOT 207010602 510K: K083124 ETN MANUFACTURED MAY 15, 2013 (B)(4). PRODUCT EVALUATION: DEVICE ANALYSIS IS NOT AVAILABLE; EVALUATION IN PROGRESS, BUT NOT YET COMPLETE. METHOD: NO TESTING METHODS PERFORMED. RESULTS: RESULTS PENDING COMPLETION OF EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE MANUFACTURER RECEIVED: JUNE 18, 2014. PRODUCT EVALUATION: RECEIVED NIM 3.0 MAINFRAME, PATIENT INTERFACE, PATIENT SIMULATOR, AND MUTING PROBE FOR EVALUATION BY THE ENGINEERING GROUP. THE CONDITION OF THE DEVICE SHOWED NO SIGNIFICANT PHYSICAL DAMAGES. A 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 MUTING PROBE IMPEDANCE WAS WITHIN SPEC. THE DEVICES WERE RELEASED TO SERVICE AND REPAIR FOR PROCESSING. SERVICE AND REPAIR EVALUATED THE NIM RESPONSE MAINFRAME 8253001, S/N (B)(4), AND COULD NOT VERIFY THE CUSTOMER¿S ISSUE. UPGRADED SOFTWARE TO CURRENT SPECIFICATION. AS A PRECAUTIONARY MEASURE, PLACED UNIT IN BURN-IN FOR 24 HOURS ATTEMPTING TO OBSERVE ANY HEAT RELATED FAILURE. UNIT NEVER FAILED. THE UNIT WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. EVALUATION OF THE NIM RESPONSE INTERFACE 8253200, S/N (B)(4), COULD NOT VERIFY THE CUSTOMER¿S ISSUE. REPLACED WAVE WASHER DUE TO CABLE CLIP LOOSE. THE ITEM WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. (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 DEVICE DOES NOT SEEM TO BE RESPONDING THE WAY IT SHOULD; THE MAINFRAME IS ¿NOT ALARMING¿. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302871 MAINFRAME 8253001 NIM RESPONSE 3.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 207018510

    Patients

    Seq Age Sex Outcome Treatment
    1