BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2161073 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00112
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    December 16, 2009
    Report Date
    December 31, 2009
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P02
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE TECH EXAMINED THE SYSTEM AND DETERMINED THE ROOT CAUSE WAS A SOFTWARE ERROR. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS A VERTEX DISTANCE ISSUE. THE VERTEX DISTANCE ON THE SUMMARY SCREEN APPEARS 1.000.000 WHEN THE PT IS PICKED AND F6 IS PRESSED TO CONTINUE TREATMENT LEVEL. THE TREATMENT ITSELF WAS EXECUTED AT VERTEX DISTANCE 232. NO PT HARM WAS REPORTED AND NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990631 NA

    Patients

    Seq Age Sex Outcome Treatment
    1