BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 5000387 · Received August 5, 2015

    Report

    Report Number
    3004378299-2015-00065
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 13, 2015
    Report Date
    August 5, 2015
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K102749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO INTERNAL COMPONENTS FAILURE, COMBINED TO POOR MAINTENANCE. AFTER THE REPLACEMENT OF THESE COMPONENTS AND THE OVERALL SYSTEM CONTROLS, THE LASER SYSTEM RESTARTED TO WORK CORRECTLY.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM:: "LOW POWER OUTPUT AND CHILLER 2 FLOW SENSOR ERROR". NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518090 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. CYBER TM 150

    Patients

    Seq Age Sex Outcome Treatment
    1