BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3232308 · Received December 21, 2012

    Report

    Report Number
    3004378299-2012-00024
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 20, 2012
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K090962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO CHILLER UNITS HAD USED UP THE THERMAL EXCHANGE GAS. THESE CHILLERS WERE REPLACED AND THE LASER SYSTEM RETURNED TO WORK. WE ARE UNAWARE ABOUT DELAY IN TREATMENT OR PT INJURY.

    Description of Event or Problem · 1

    THE TWO CHILLER UNITS DID NOT MAINTAIN THE TEMPERATURE SET POINT. 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. CYBER TM 120

    Patients

    Seq Age Sex Outcome Treatment
    1