BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM

    MDR report key: 4002179 · Received August 6, 2014

    Report

    Report Number
    3004378299-2014-00062
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K102749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DIODE LASER CHANNELS WERE OBSTRUCTED. AFTER THE MANUAL CLEANING THE LASER WAS RESTORED TO FULL WORKING CONDITION. WE ARE UNAWARE ABOUT PATIENT INJURY.

    Description of Event or Problem · 1

    IN SURGICAL LASER SYSTEM, CYBER TM "ALARM FLOW" AT CHILLER 2 HAS BEEN DISPLAYED. FOR A SHORT PERIOD OF TIME THE LASER WAS NOT WORKING. WE ARE UNAWARE OF ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461023 QUANTA SYSTEM SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. CYBER TM 150

    Patients

    Seq Age Sex Outcome Treatment
    1