BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3972824 · Received July 25, 2014

    Report

    Report Number
    3004378299-2014-00054
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 21, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K102749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO A DAMAGED CHILLER. AFTER THE REPLACEMENT OF THIS COMPONENT, THE LASER SYSTEM RESTARTED TO WORK. WE ARE UNAWARE ABOUT PATIENT INJURY.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: "CHILLER SHUTS DOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436012 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. CYBER TM 150

    Patients

    Seq Age Sex Outcome Treatment
    1