BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EC-5000 QUEST

    MDR report key: 7016192 · Received November 9, 2017

    Report

    Report Number
    0002936921-2017-00024
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    October 24, 2017
    Report Date
    November 9, 2017
    Manufacturer
    NIDEK INC.
    Product Code
    LZS
    PMA / PMN Number
    P970053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NIDEK INC. CONSIDERS GAS LEAK ISSUE ON EXCIMER LASER A REPORTABLE EVENT AS THE EC-5000 QUEST HAD MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. . ON (B)(6) 2017 A NIDEK FIELD SERVICE ENGINEER(FSE) EVALUATED THE DEVICE AT THE USER FACILITY AND OBSERVED THE CONNECTED NITROGEN TANK WAS EMPTY. THE FSE COULD NOT SMELL ANY PREMIX GAS BECAUSE THE PREMIX TANK WAS CLOSED, DUE TO THE A1/A2 GAUGES NOT HOLDING PRESSURE. FSE NOTED THAT THE A1 AND A2 GAUGES OF THE PREMIX REGULATOR WERE AT 0 MPA CAUSING THE PRESSURE NOT HOLDING WHEN TESTING WITH HELIUM FLOWING THROUGH THE BYPASS VALVE. .FSE REMOVED THE REAR COVER AND REPLACED THE LEAK VALVE. HELIUM LEAK TESTED AND PASSED. CHECKED THE F2 SENSOR BOARD VOLTAGES : TP1=0.400 V, TP2=1.002 V, TP3=1.40 V. INSTALLED THE EXHAUST DUCT TO THE BACK OF THE CONSOLE. . AS OF (B)(6) 2017 FSE REPAIRED THE GAS PROBLEM BY REPLACING THE CHECK VALVE, HOWEVER COULD NOT COMPLETE THE SERVICE DUE TO EMPTY NITROGEN BOTTLE AND A FOLLOW UP SERVICE AND STAFF TRAINING WERE SCHEDULED AFTER NEW NITROGEN TANKS WERE BROUGHT IN. .ON OCTOBER 31,2017 FSE WAS AT THE USER FACILITY FOR FOLLOW UP SERVICE ACTIVITIES. CUSTOMER ORDERED A NEW NITROGEN BOTTLE AND EXCHANGED THE NITROGEN BOTTLE BEFORE FSE ARRIVED. FSE TURNED ON LASER AND FOUND IN WORKING ORDER. PERFORMED ABLATION RATE CALIBRATION AS PER SECTION 5.3 OF THE OPERATORS MANUAL FOR EC-5000 QUEST. ALSO, CHECKED NEW GAS FILL. TESTED AND INSPECTED SYSTEM. RETRAINED TECHNICIANS ON OPERATION OF QUEST LASER. SYSTEM IS OPERATIONAL. .IN CONCLUSION, NIDEK INCORPORATED DETERMINED THAT THE PROBABLE CAUSE OF THE EXCIMER LASER GAS LEAKAGE ISSUE WAS DUE TO A DEFECTIVE CHECK/LEAK VALVE COMPONENT. THE DEVICE FUNCTIONS PROPERLY AND NO GAS LEAK DETECTED AFTER THE CHECK/LEAK VALVE COMPONENT WAS REPLACED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, NIDEK INC. CUSTOMER SERVICE RECEIVED A TELEPHONE CALL FROM A CUSTOMER TO REPORT THAT THEY WERE SMELLING PREMIX GAS WHILE THEY WERE CHANGING THE PREMIX TANK BY FOLLOWING GUIDELINES ON THE DEVICE'S SCREEN ON THEIR EC-5000 QUEST SERIAL (B)(4). THERE WAS NO INJURY REPORTED AS THE CUSTOMER SERVICE INSTRUCTED TO CLOSE THE GAS BOTTLE AND LEAVE THE ROOM IMMEDIATELY IN ORDER TO AVOID ANY INJURY. SURGERIES WERE CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793044 EC-5000 QUEST NIDEK EXCIMER LASER QUEST LZS NIDEK INC.

    Patients

    Seq Age Sex Outcome Treatment
    1