BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2160905 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00146
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ONSITE INVESTIGATION, THE SERVICE TECH COULD NOT FIND ANY ERROR WITH THE SYSTEM. THE SYSTEM WAS RETURNED TO TECHNICAL CUSTOMER SERVICE AND EXAMINED. ERROR MESSAGES WERE ASSESSED TO BE EXPECTED, WITH USE OF DEVICE. CONSEQUENTLY, SYSTEM WAS IN SAFE CONDITION, NO RISK TO PT OR TREATMENT. ROOT CAUSE COULD NOT BE IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN REPORTS SIX ABORTED TREATMENTS DUE TO DIFFERENT SYSTEM ERROR MESSAGES. NO PT HARM REPORTED AND NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1