BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3232316 · Received December 18, 2012

    Report

    Report Number
    3004378299-2011-00018
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    September 21, 2011
    Report Date
    December 14, 2012
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K100558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS IN THE FAN OF HEAT SINK SYSTEM, THE FAN WAS RESET AND THE LASER SYSTEM CORRECTLY WORKED. WE ARE UNAWARE ABOUT DELAY ON TREATMENT OR PT INJURY.

    Description of Event or Problem · 1

    THE LASER SYSTEM SHOWED TEMPERATURE ALARM AT 40 DEGREES CELSIUS. WE ARE UNAWARE ABOUT DELAY ON TREATMENT OR PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM S.P.A. IG-1470

    Patients

    Seq Age Sex Outcome Treatment
    1