BEUDAMED
    FDA Adverse Event Other Summary report: N

    GIRAFFE SPOT PT LIGHT

    MDR report key: 705141 · Received April 25, 2006

    Report

    Report Number
    1121732-2006-00013
    Event Type
    Other
    Date Received
    April 25, 2006
    Date of Event
    March 30, 2006
    Report Date
    April 25, 2006
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    LBI
    Removal / Correction Number
    Z-0160-6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SPOT PT LIGHT MOUNTED ON AN IWS 4400 UNIT (AN OPEN ENVIRONMENT). GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *