BEUDAMED
    FDA Adverse Event Other Summary report: N

    GIRAFFE SPOT PHOTOTHERAPY LIGHT

    MDR report key: 547988 · Received October 8, 2004

    Report

    Report Number
    1121732-2004-00014
    Event Type
    Other
    Date Received
    October 8, 2004
    Date of Event
    September 8, 2004
    Report Date
    October 8, 2004
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    LBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A GIRAFFE SPOT PHOTOTHERAPY LIGHT DROPPED DOWN AND CAUSED A REDDENED AREA ON THE PT'S ABDOMEN. THE LIGHT WAS APPROX. 6"-8" FROM THE PT. THE LIGHT WAS FREE STANDING AND NOT ATTACHED TO A BED. THE UNIT WAS TESTED BY AN OHMEDA MEDICAL ENGINEER AND NO PROBLEMS WERE FOUND. NO OTHER INFORMATION WAS AVAILABLE FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE SPOT PHOTOTHERAPY LIGHT PHOTOTHERAPY LBI OHMEDA MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY Other