BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3232334 · Received January 4, 2013

    Report

    Report Number
    3004378299-2012-00036
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    September 20, 2012
    Report Date
    January 4, 2013
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K090962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO HARD DISK MEMORY INSIDE THE MONITOR UNIT. AFTER THE REPLACEMENT OF THE HARD DISK, THE LASER SYSTEM RESTARTED TO WORK. WE ARE UNAWARE ABOUT DELAY ON TREATMENT OR PT INJURY.

    Description of Event or Problem · 1

    IN THE LASER SYSTEM, THE MONITOR DID NOT WORK. WE ARE UNAWARE ABOUT DELAY ON TREATMENT OR PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6440 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM S.P.A. CYBER TM 120

    Patients

    Seq Age Sex Outcome Treatment
    1