BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMR 2000 TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE

    MDR report key: 4352803 · Received December 22, 2014

    Report

    Report Number
    2950727-2014-00026
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Date of Event
    December 9, 2014
    Report Date
    December 9, 2014
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CRYOLIFE WAS INFORMED THAT DURING A PREVENTATIVE MAINTENANCE (PM) ON TRANSMYOCARDIAL REVASCULARIZATION (TMR) LASER (S#(B)(4)), THE LASER WOULD SHUT DOWN IF THE KEY WAS FLEXED IN THE KEY SWITCH. THE LASER SYSTEM IS 15 YEARS OLD AND IT IS NOT UNUSUAL FOR THE SWITCH TO WEAR IN THIS MANNER. THE KEY SWITCH WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO USER COMPLAINT OF THIS HAPPENING AND SPECIALTY TEAM MANAGER FOR CARDIAC SURGERY, (B)(6) STATED THAT SHE HAD NOT HAD ANY INCIDENT OF SYSTEM SHUT DOWN. A REPORT WAS ISSUED STATING THAT THERE IS NOT A SERVICE CONTRACT WITH THE ACCOUNT AND THEREFORE NO PREVIOUS SERVICE RECORDS EXIST ON FILE FOR THE LASER. CRYOLIFE ISSUED A NO CHARGE PURCHASE ORDER (PO) FOR A ONE TIME PREVENTATIVE MAINTENANCE ON THE UNIT AS THE HOSPITAL HAD REQUESTED THE SYSTEM BE CHECKED OUT SINCE IT HAD NOT BEEN DONE IN SOME TIME. THE EVENT COULD BE DUPLICATED BY MANIPULATING THE KEY IN THE KEY SWITCH, WHICH WOULD CAUSE SYSTEM TO CYCLE OFF. THERE WAS NO FURTHER INSPECTION OF THE KEY SWITCH AND DIAGNOSTICS AFTER REPLACING THE FAULTY KEY SWITCH. WORN KEY SWITCH WAS REPLACED WITH A NEW KEY SWITCH (SP2276) DURING THE SCHEDULED ROUTINE PREVENTATIVE MAINTENANCE CYCLE. THERE WAS NO EVIDENCE TO SUGGEST THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE. ALL STEPS OF THE QUALITY ASSURANCE VERIFICATION WERE COMPLETED, INCLUDING A STARTUP OF THE CONSOLE VIA THE KEY SWITCH, AS WELL AS THE FINAL TEST LASER POWER OUTPUT WITH ALL RESULTS BEING WITHIN SPECIFICATION RANGES. THERE WERE NO PROBLEMS REQUIRING CORRECTIVE ACTION DOCUMENTED ON THE FINAL PRODUCT CORRECTIVE ACTION LIST PORTION OF THE FINAL TEST/QUALITY ASSURANCE PROCEDURE. THERE WERE NO ADDITIONAL NON-CONFORMANCES OR REWORKS INCLUDED IN THE MANUFACTURING AND FINAL INSPECTION RECORDS.

    Description of Event or Problem · 1

    DURING A PREVENTATIVE MAINTENANCE ON TMR LASER (S#(B)(4)),THE LASER WOULD SHUT DOWN IF THE KEY WAS FLEXED IN THE KEY SWITCH. THE LASER SYSTEM IS 15 YEARS OLD AND IT IS NOT UNUSUAL FOR THE SWITCH TO WEAR IN THIS MANNER. THE KEY SWITCH WAS REPLACED AND THE ISSUE WAS RESOLVED. THE COMPLAINANT STATED THAT SHE HAD NOT HAD ANY INCIDENT OF SYSTEM SHUT DOWN.

    Description of Event or Problem · 1

    DURING A PREVENTATIVE MAINTENANCE ON TMR LASER ((B)(4)),THE LASER WOULD SHUT DOWN IF THE KEY WAS FLEXED IN THE KEY SWITCH. THE LASER SYSTEM IS 15 YEARS OLD AND IT IS NOT UNUSUAL FOR THE SWITCH TO WEAR IN THIS MANNER. THE KEY SWITCH WAS REPLACED AND THE ISSUE WAS RESOLVED. THE COMPLAINANT STATED THAT SHE HAD NOT HAD ANY INCIDENT OF SYSTEM SHUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843015 TMR 2000 TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE MNO CARDIOGENESIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other