BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2160875 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00151
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    March 1, 2009
    Report Date
    March 13, 2009
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P0
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPORADIC FAILURES HAVE BEEN CAUSED BY A TOO SMALL CURRENT SUPPLY DURING THE IGNITION PROCESS. CONSEQUENTLY, THE DISPLAY INVERTER WAS CHANGED. THE ROOT CAUSE WAS A FAULTY MONITOR. THE REFERENCE TO THE IGNITION PROCESS WAS THAT THE POWER SOURCE FOR THE LCD BACKLIGHT WAS INOPERATIVE,CAUSING THE DISPLAY MONITOR TO BE FAULTY. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DISPLAY BACKGROUND ILLUMINATION DID NOT WORK. THIS EVENT OCCURRED DURING SURGERY, HOWEVER, THERE WAS NO INJURY REPORTED.

    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