BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM

    MDR report key: 3232321 · Received December 18, 2012

    Report

    Report Number
    3004378299-2011-00007
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    July 28, 2011
    Report Date
    December 13, 2012
    Manufacturer
    QUANTA SYSTEM SPA
    Product Code
    GEX
    PMA / PMN Number
    K090962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    RESONATOR DIODE DAMAGE BECAUSE OF INTERNAL CONTAMINATION OF OPTICAL COMPONENTS.

    Description of Event or Problem · 1

    SURGICAL LASER IS NOT ABLE TO FINISH THE BOOT UP. FAILURE OF THE INITIAL CHECK DURING START UP. LOW POWER INDICATED. CURRENT CHECK ALARM DISPLAYED ON MONITOR. NO OTHER ALARM OR ERROR IS DISPLAYED ON POWER SUPPLY. UNAWARE OF THE PRESENCE OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTA SYSTEM SURGICAL LASER GEX QUANTA SYSTEM SPA CYBER TM 120

    Patients

    Seq Age Sex Outcome Treatment
    1