BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2160885 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00148
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 19, 2008
    Report Date
    June 19, 2008
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPLACED THE FUSE, NO SERVICE VISIT WAS REQUIRED. ROOT CAUSE WAS DETERMINED TO BE A FAULTY FUSE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE SWIVEL BED LOST POWER. THE FUSE WAS REPLACED AND THE BED POWERED UP. NO PT HARM WAS REPORTED AND NO FURTHER INFO 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 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1