BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 4912452 · Received July 10, 2015

    Report

    Report Number
    3004378299-2015-00057
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 8, 2015
    Report Date
    July 9, 2015
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K141101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO A COMPONENT FAILURE (COMPACT CHARGER). AFTER THE REPLACEMENT OF THIS COMPONENT, THE LASER SYSTEM RESTARTED TO WORK CORRECTLY. WE ARE UNAWARE ABOUT PATIENT INJURY.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: "SIMMERING ERROR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448947 QUANTA SYSTEM S.P.A. GEX QUANTA SYSTEM, S.P.A. LITHO

    Patients

    Seq Age Sex Outcome Treatment
    1