BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARGEN 2100S TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE

    MDR report key: 4137549 · Received October 3, 2014

    Report

    Report Number
    2950727-2014-00024
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED LASER SHUT DOWN DURING CASE. I CONTACTED ACCOUNT AND SPOKE TO (B)(6) (NURSE IN OR DURING CASE). SHE SAID LASER SHUT DOWN AFTER 40 CHANNELS. THEY TRIED A SEPARATE PLUG AND CORD, BUT WERE UNABLE TO TURN ON LASER. ADDITIONAL INFORMATION WAS RECEIVED ON THIS INCIDENT FROM (B)(6), THE PERFUSIONIST IN THE ROOM WHEN THE EVENT OCCURRED. THERE WAS NO PATIENT IMPACT AS 40 CHANNELS WERE COMPLETED AND THE SURGEON, DR. (B)(6) DETERMINED THIS WAS SUFFICIENT. ADDITIONALLY, THE TYPE AND SERIAL NUMBER OF THE LASER CONSOLE WAS IDENTIFIED AS SG-2100 AND (B)(4), RESPECTIVELY. DR. (B)(6) WAS DOING A TMR PROCEDURE AND THE LASER CONSOLE SHUT DOWN (POWERED OFF). THEY TRIED TO TURN THE CONSOLE ON, TRIED A DIFFERENT OUTLET AND PLUG, BUT THE LASER CONSOLE WOULD NOT TURN ON. THE PLUG WAS FOUND TO BE HOT. DR (B)(6) ASKED AND WAS TOLD THAT HE WAS ON TMR LASER CHANNEL 40 AND DETERMINED THAT WAS SUFFICIENT. DR (B)(6) WAS CONTINUOUSLY FIRING LASER WHILE COMPLETING THE 40 CHANNELS WITH NO REST BETWEEN. (B)(6),THE NURSE TECH IN ROOM, STATED THAT LASER WAS PLUGGED INTO A RED EMERGENCY OUTLET, NOT A DEDICATED OUTLET. WHEN A SERVICE ENGINEER ARRIVED TO SERVICE LASER, HE FOUND ONE OF THE 15A BREAKERS ON THE REAR OF LASER WAS TRIPPED. AFTER RESETTING BREAKER, HE TESTED LASER AND FOUND IT TO BE WORKING WITHIN FACTORY SPECIFICATION (NO CHANGE FROM PREVIOUS SERVICE IN JUNE 2014). I REPLACED BOTH 15A BREAKERS ON THE REAR OF LASER (EVERY TIME A BREAKER TRIPS IT WEAKENS. THESE WERE REPLACED AS A PRECAUTION DUE TO THIS). THE MOST LIKELY ROOT CAUSE TO THE REPORTED EVENT IS THE CONSOLE WAS PLUGGED IN TO A NON- DEDICATED OUTLET. THE IFU PROVIDES THE FOLLOWING INSTRUCTIONS IF THE LASER CONSOLE SHUTS DOWN, "POSSIBLE CAUSE: WALL OUTLET CIRCUIT BREAKERS TRIPPED OFF. MAJOR SYSTEM FAULT OCCURRED. SOLUTION: CHECK FACILITY WALL CIRCUIT BREAKERS AND RESET. CHECK LASER CIRCUIT BREAKERS AND RESET. CONTACT CUSTOMER SERVICE." THE IFU ALSO STATES "A DEDICATED OUTLET IS REQUIRED FOR THE PROPER OPERATION OF THE LASER CONSOLE." A REVIEW OF THE MANUFACTURING AND SERVICE RECORDS HAS BEEN PERFORMED. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    REPORTED LASER SHUT DOWN DURING CASE. I CONTACTED ACCOUNT. THEY SAID LASER SHUT DOWN AFTER 40 CHANNELS. THEY TRIED A SEPARATE PLUG AND CORD, BUT WERE UNABLE TO TURN ON THE LASER.

    Description of Event or Problem · 1

    REPORTED LASER SHUT DOWN DURING CASE. I CONTACTED ACCOUNT. THEY SAID LASER SHUT DOWN AFTER 40 CHANNELS. THEY TRIED A SEPARATE PLUG AND CORD, BUT WERE UNABLE TO TURN ON THE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618831 SOLARGEN 2100S TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE TRANSMYOCARDIAL REVASCULARIZATION LASER SYSTEM MNO CARDIOGENESIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other