BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTHALMIC ARGON LASER

    MDR report key: 863274 · Received May 18, 2007

    Report

    Report Number
    863274
    Event Type
    Malfunction
    Date Received
    May 18, 2007
    Date of Event
    February 5, 2007
    Report Date
    May 18, 2007
    Manufacturer
    LUMENIS INC.
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PROBLEM IS THAT THE AIMING BEAM WAS DIM. BIOMED SENT THE DEVICE TO THE MFR FOR REPAIR AS IT IS UNDER WARRANTY. THE MFR ALIGNED THE LASER AND RETURNED IT TO OUR FACILITY A FEW WEEKS LATER. IT WAS RETURNED TO SERVICE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPHTHALMIC ARGON LASER LASER HQF LUMENIS INC. NOVUS SPECTRA *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR