BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2160977 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00177
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    March 23, 2010
    Report Date
    March 23, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P02
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ONSITE INVESTIGATION, THE SERVICE TECH REPLACED THE SHUTTER. ROOT CAUSE WAS IDENTIFIED AS A FAULTY SHUTTER. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS AN ENERGY ERROR MESSAGE DUE TO 'JAMMING' THE SHUTTER. NO PATIENT HARM REPORTED AND NO FURTHER INFORMATION 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