BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8253001 NIM RESPONSE 3.0

    MDR report key: 3308723 · Received August 26, 2013

    Report

    Report Number
    1045254-2013-00502
    Event Type
    Malfunction
    Date Received
    August 26, 2013
    Date of Event
    July 26, 2013
    Report Date
    August 2, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 8253200, PATIENT INTERFACE; 8253200, RESPONSE 3.0, S/N: (B)(4), LOT: 205640133, 510K: K083124, ETN MANUFACTURED 1-5-2012, RECEIVED FOR EVALUATION (B)(4) 2013; 8229307, ENDOTRACHEAL TUBE; 8229307, NIM EMG 7MM RE, S/N AND LOT UNKNOWN, 510K: K925640, ETN MANUFACTURED: UNABLE TO DETERMINE WITHOUT LOT NUMBER, NOT RETURNING, DISCARDED. (B)(4). PRODUCT EVALUATION: RECEIVED NIM 3.0 MAINFRAME AND INTERFACE FOR EVALUATION BY THE ENGINEERING GROUP. THE CONDITION OF THE DEVICE SHOWED THAT THE MAINFRAME WAS MISSING A RUBBER FOOT AND THE WAVE WASHERS IN THE INTERFACE¿S CLIPS WERE WORN; HOWEVER, THESE ARE EXTERNAL MECHANICAL PARTS THAT DO NOT AFFECT THE UNITS¿ FUNCTIONALITY. THE INTERFACE AND SIMULATOR 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. ELECTRODE CHECK WAS WITHIN ACCEPTABLE RANGES FOR ALL CHANNELS, STIM 1 AND 2, AND GROUND. SERVICE AND REPAIR COULD NOT VERIFY CUSTOMER'S ISSUE WITH THE MAINFRAME (8253001). THE UNIT HAD THE OLD SOFTWARE; REPLACED CF CARD TO UPGRADE SOFTWARE AND INSTALLED MISSING FEET RIVET. AS A PRECAUTIONARY MEASURE, PLACED UNIT IN BURN-IN FOR 4 HOURS ATTEMPTING TO OBSERVE ANY HEAT RELATED FAILURE. UNIT NEVER FAILED. UNIT WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. SERVICE AND REPAIR COULD NOT DUPLICATE CUSTOMER¿S COMPLAINT WITH THE INTERFACE (8253200), HOWEVER, THIS PATIENT INTERFACE CABLE CAME IN WITH THE BACK CLIP LOOSE; REPLACED THE WASHER ON THE CLIPS. THE ITEM WAS CLEANED, TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. THE EMG TUBE (8229307) WILL NOT BE EVALUATED; IT WAS DISCARDED AFTER THE PROCEDURE. THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED NOR CONFIRMED. PER THE INSTRUCTIONS FOR USE FOR THE EMG TUBE (8229307): AVOID DAMAGE TO THE TRACHEA, LARYNX OR VOCAL CORDS DURING INSERTION BY INSPECTING THE TUBE, CUFF, AND MONITORING CONNECTIONS FOR DAMAGE, WHICH MAY OCCUR IF THE CUFF IS OVER INFLATED DURING SET-UP TESTING. AVOID FALSE NEGATIVE RESPONSES (FAILURE TO LOCATE NERVE), WHICH MAY BE CAUSED BY: NEUROMUSCULAR FATIGUE FROM PROLONGED OR REPEATED EXPOSURE TO ELECTRICAL STIMULI. DEEP ANESTHESIA, WHICH MAY SUPPRESS NEUROELECTRICAL ACTIVITY OF THE RECURRENT LARYNGEAL NERVE. INSUFFICIENT CONTACT BETWEEN THE ELECTRODES AND VOCAL CORDS DUE TO MISPLACEMENT OR USING A TUBE SIZE THAT IS TOO SMALL. DISPLACEMENT DURING THE PROCEDURE WHEN ROTATING THE PATIENT¿S HEAD AND NECK. THE PROPER SIZE TUBE FOR THE INDIVIDUAL PATIENT SHOULD BE DETERMINED PRIOR TO INTUBATION BY THE ANESTHESIA PROVIDER AND/OR SURGEON. A TUBE THAT IS ONE SIZE LARGER THAN STANDARD SELECTION IS RECOMMENDED WHENEVER POSSIBLE TO IMPROVE ELECTRODE CONTACT WITH VOCAL CORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NERVE JUMPED IN THE CASE, BUT NOT ON THE MACHINE. IT WAS CLARIFIED THAT DURING SET UP FOR A THYROIDECTOMY, THE START-UP SCREEN ON THE MONITOR SHOWED GREEN CHECKS, INDICATING GOOD CONNECTIONS. WHEN STIMULATING THE RIGHT SIDE THE PHYSICIAN COULD SEE THE NERVE REACT AND JUMP, BUT THERE WAS NO RESPONSE ON THE MONITOR SCREEN. THE LEFT SIDE WORKED AS EXPECTED. THEY FELT THAT THIS WAS A FALSE NEGATIVE. THEY DID QUESTION WHETHER THE EMG TUBE WAS TOO SMALL. AFTER THE PROCEDURE THE PATIENT HAD WEAKNESS OF HER VOICE; SHE HAS YET TO RETURN FOR HER FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416991 MAINFRAME 8253001 NIM RESPONSE 3.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8253001 205562283

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR