BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTRA SYSTEM S.P.A.

    MDR report key: 3945492 · Received July 1, 2014

    Report

    Report Number
    3004378299-2014-00049
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 30, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K102749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO DEFECTIVE CHILLER I. AFTER THE REPLACEMENT OF THIS COMPONENT, THE LASER SYSTEM RESTARTED TO WORK. WE ARE UNAWARE ABOUT PT INJURY.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: "ERROR FLOR-SENSOR 1, AND THERE IS NO FLOW OF WATER CHILLER 1."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381956 QUANTRA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. CYBER TM 200

    Patients

    Seq Age Sex Outcome Treatment
    1