BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 2160979 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00159
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    September 3, 2009
    Report Date
    September 3, 2009
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER ASSISTANCE WAS PROVIDED VIA PHONE. AFTER CUSTOMER REBOOTED THE SOFTWARE, THE ISSUE RESOLVED. INSUFFICIENT INFO TO DETERMINE THE ROOT CAUSE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS A LOSS OF EYETRACKER IMAGE ON THE USER SCREEN. NO PT HARM REPORTED AND NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 6065990602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1