BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 2160974 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00178
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    November 23, 2009
    Report Date
    November 23, 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

    EVALUATION TOOK PLACE AND INFORMATION WAS GIVEN TO THE PROGRAMMING DEPARTMENT. ROOT CAUSE WAS IDENTIFIED AS A SOFTWARE RELATED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE DATA FROM THE ANALYZER CANNOT BE USED FOR THE TREATMENT; RECEIVED A SYSTEM MESSAGE. NO PATIENT IMPACT WAS REPORTED AND NO FURTHER INFORMATION 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