BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYS S.P.A.

    MDR report key: 4237305 · Received August 29, 2014

    Report

    Report Number
    3004378299-2013-00067
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 26, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K100558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE WAITING FOR ADDITIONAL INFO FROM THE DIST.

    Description of Event or Problem · 1

    THE LASER SYS HAS THE FOLLOWING PROBLEM: "UNIT WILL NOT TURN ON".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527711 QUANTA SYS S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. QUANTA B

    Patients

    Seq Age Sex Outcome Treatment
    1