BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-ECLIPSE® CONTROLLER

    MDR report key: 4863211 · Received June 23, 2015

    Report

    Report Number
    1045254-2015-00216
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 27, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    PMA / PMN Number
    K050798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: 05/27/2015. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER: 07/06/2015. DATE RECEIVED BY MANUFACTURER: 09/02/2015. PRODUCT EVALUATION: RECEIVED NIM ECLIPSE SYSTEM FOR EVALUATION BY THE ENGINEERING GROUP. THE CONDITION OF THE DEVICES SHOWED NO SIGNIFICANT PHYSICAL DAMAGES. A SHAKE TEST WAS PERFORMED ON THE COMPONENTS; NO LOOSE PARTS WERE HEARD. THE ECLC, 2 DAQ916'S, 2 EEX901'S, AND CABLES WERE CONNECTED TO THE LAPTOP AND TURNED ON; BOOT-UP SEQUENCE COMPLETED WITH NO ERRORS. A MONITORING MODE WAS SELECTED USING ALL AVAILABLE CHANNELS AND APPROPRIATE RESPONSES WERE SEEN ON ALL CHANNELS. ACCESSIBLE ENERGIZED PARTS CAPABLE OF CAUSING ELECTRICAL SHOCK COULD NOT BE DETECTED ON ANY COMPONENTS. THE COMPLAINT FOR THE REPORTED MALFUNCTION, SHOCKS PEOPLE, COULD NOT BE CONFIRMED. THE DEVICES WERE SENT FOR FURTHER TESTING. THE CONTROLLER 945ECLC ECLIPSE WAS POWERED ON; THE SELF-TEST FAILED. STIM MODULES NOT COMMUNICATING WITH THE ECLC. ALL OTHER ELECTRICAL TESTING PASSED. THE STIM BOARD WAS REPLACED IN THE UNIT, WHICH THEN PASSED ALL FUNCTIONAL TESTING, INCLUDING SHAKE TESTING AND HIGH TEMPERATURE CONDITIONS. THE SYSTEM WAS RETURNED TO THE CUSTOMER. -- SUMMARY OF ANALYSIS: * COULD NOT VERIFY THAT THE UNIT (945ECLC) HAD A CURRENT PATH FROM THE CHASSIS TO L1 THAT WOULD CAUSE SOMEONE TO FEEL ELECTRICAL CURRENT WHEN TOUCHING THE UNIT. THE DEVICE DID FAIL THE FLUKE BIOMEDICAL TEST AT REPAIR FACILITY INCOMING TEST. THE INSULATION RESISTANCE AT 25 AMPS WAS 200K. THE MINIMUM INSULATION RESISTANCE IS 2 MEG. THE PATIENT LEAKAGE CURRENT FAILED AT 25 AMPS. IT MEASURED 359UA. MAXIMUM LEAKAGE CURRENT IS 100UA. THIS STILL SHOULD NOT HAVE HAD SUFFICIENT ENERGY FOR THE PATIENT TO FEEL ANY ELECTRICAL CURRENT AND THIS COULD NOT BE REPLICATED IN THE LAB. THE STIM BOARD FAILED SELF-TEST, THEREFORE IT WAS REPLACED. THE UNIT (945ECLC) SUBSEQUENTLY PASSED ALL BUILT IN SELF-TESTS, HIPOT TESTS, FLUKE BIOMEDICAL TESTS AND FUNCTIONAL TESTS. ANALYSIS OF 945DAQ916, S/N (B)(4), FOUND NO FAULT WITH THE DEVICE. THE ITEM WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. ANALYSIS OF 945DAQ916, S/N (B)(4), FOUND NO FAULT RELATING TO THE ¿ELECTRICAL SHOCK¿; HOWEVER, THE ITEM FAILED TO BE RECOGNIZED DURING THE CALIBRATION TEST. REPLACED ALL THREE BOARDS AS A PRECAUTION. THE ITEM WAS TESTED AND PASSED MANUFACTURING SPECIFICATIONS. ANALYSIS OF 945EEX901, S/N (B)(4), FOUND NO FAULT WITH THE DEVICE. THE ITEM WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. ANALYSIS OF 945EEX901, S/N (B)(4), FOUND NO FAULT WITH THE DEVICE. THE ITEM WAS UPDATED TO CURRENT DESIGN SPECIFICATIONS. THE ITEM WAS TESTED AND PASSED MANUFACTURING SPECIFICATIONS. ANALYSIS OF 945CEEX98 FOUND NO FAULT WITH THE DEVICE. THE ITEM WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL DEVICES: 945DAQ916: AMPLIFIER 945DAQ916 DIG PREAMPLIFIER, S/N (B)(4), LOT 205845291 MANUFACTURED 04/26/2012 -- 945DAQ916: AMPLIFIER 945DAQ916 DIG PREAMPLIFIER, S/N (B)(4), LOT 205848229 MANUFACTURED 04/26/2012 -- 945EEX901: EXTENDER 945EEX901 STIMULATOR, S/N (B)(4) -- 945EEX901: EXTENDER 945EEX901 STIMULATOR, S/N (B)(4) -- 945CEEX98: CABLE 945CEEX98 8FT STIMULATOR. (B)(4). PRODUCT EVALUATION: NO ANALYSIS RESULTS AVAILABLE; SYSTEM HAS NOT BEEN RECEIVED IN FOR EVALUATION.

    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 SYSTEM SHOCKED A PERSON AFTER THE CASE FINISHED. THE CART THAT IT WAS SITTING ON THE DEVICE BECAME ELECTRIFIED. A PERSON TOUCHED THE CART AND RECEIVED A SHOCK. THE SHOCK WAS DESCRIBED AS AN ELECTRIC SHOCK. IT WAS CONFIRMED THAT NO ONE REQUIRED MEDICAL ATTENTION OR SUSTAINED ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406008 NIM-ECLIPSE® CONTROLLER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 945ECLC 205854756

    Patients

    Seq Age Sex Outcome Treatment
    1