BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3232338 · Received December 18, 2012

    Report

    Report Number
    3004378299-2011-00009
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    August 6, 2011
    Report Date
    December 31, 2012
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K090962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACED THE FLOWMETER WITH FAILURE. THE EVENT DID NOT CREATE INJURY TO PT BECAUSE THE LASER CANNOT WORK. WE ARE NOT AWARE ON EVENTUAL DELAY ON THE TREATMENT.

    Description of Event or Problem · 1

    THIS DEVICE IS A SURGICAL LASER. THE FLOW METER OF A CHILLER UNIT HAD A FAILURE AT START UP. EXCHANGING THE FLOW METER, THE LASER CORRECTLY STARTED UP. 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