BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 2160906 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00149
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    December 22, 2008
    Report Date
    December 22, 2008
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ON-SITE INVESTIGATION, THE SERVICE TECH REPLACED THE CABLE. ROOT CAUSE WAS IDENTIFIED AS A FAULTY ILLUMINATION RING CABLE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS A FAILURE OF THE EYE TRACKER ILLUMINATION. NO PATIENT HARM WAS REPORTED AND NO ADDITIONAL 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