BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3232283 · Received December 21, 2012

    Report

    Report Number
    3004378299-2012-00016
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    June 20, 2012
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K090962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHILLER UNIT WAS REPLACED AND THE LASER SYSTEM RETURNED TO WORK. WE ARE UNAWARE ABOUT PT INJURY.

    Description of Event or Problem · 1

    IN THE CHILLER 1 THERE WAS NO WATER FLOW. PROBLEM ON FLOW SENSOR, UNABLE TO ACHIEVE A FLOW RATE ABOVE 4,0 1/MIN. WE ARE UNAWARE ABOUT 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. CYBER TM 120

    Patients

    Seq Age Sex Outcome Treatment
    1