BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE PHOTOTHERAPY LIGHT

    MDR report key: 700998 · Received April 6, 2006

    Report

    Report Number
    700998
    Event Type
    Malfunction
    Date Received
    April 6, 2006
    Date of Event
    April 1, 2006
    Report Date
    April 6, 2006
    Manufacturer
    OHMEDA MEDICAL, PART OF GE MEDICAL SYSTEMS
    Product Code
    LBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIOMED IDENTIFIED ON GIRAFFE PHOTOTHERAPY LIGHTS USED IN NICU. PROBLEM WITH LIGHTS WAS REPORTED AS LIGHTS HAVING LOW LIGHT OUTPUT. DURING INVESTIGATION, BIOMED DISCOVERED CRACKING AND DISTORTION WITH THE LIGHT PIPE ARM LOCATED AT THE END NEAR THE MIRROR. THESE CRACKS SEEM TO PREVENT LIGHT FROM TRAVELING THROUGH THE LIGHT PIPE, PREVENTING DEVICE FROM PERFORMING ITS TASK. WITH THIS CRACKING, THE OUTPUT LEVELS OF THE LIGHT ARE SEVERELY DIMINISHED, THEREFORE WE CAN NOT TREAT THE BILIRUBIN EFFECTIVELY.THE DEVICE LOCATION IS PROTECTED, SO THE DEVICE DOES NOT APPEAR TO HAVE TAKEN ANY PHYSICAL ABUSE. WE HAVE BEEN UNABLE TO DETERMINE A ROOT CAUSE, BUT THIS APPEARS TO BE A DESIGN FLAW. IT HAS BEEN IDENTIFIED NOW WITH SEVERAL UNITS. THE COMPANY REQUESTED CRACKED UNITS BE RETURNED TO THEM FOR ASSESSMENT AND REPAIR. WE HAVE BEEN TOLD THAT WE ARE THE FIRST REPORT OF THIS PROBLEM SO THE MANUFACTURER IS UNCLEAR OF THE ROOT CAUSE AND UNCLEAR HOW TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE PHOTOTHERAPY LIGHT LIGHT, PHOTOTHERAPY LBI OHMEDA MEDICAL, PART OF GE MEDICAL SYSTEMS 6600-0833-800 *
    2 GIRAFFE PHOTOTHERAPY LIGHT LIGHT, PHOTOTHERAPY LBI OHMEDA MEDICAL, PART OF GE MEDICAL SYSTEMS * *
    3 GIRAFFE PHOTOTHERAPY LIGHT LIGHT, PHOTOTHERAPY LBI OHMEDA MEDICAL, PART OF GE MEDICAL SYSTEMS * *
    4 GIRAFFE PHOTOTHERAPY LIGHT LIGHT, PHOTOTHERAPY LBI OHMEDA MEDICAL, PART OF GE MEDICAL SYSTEMS * *
    5 GIRAFFE PHOTOTHERAPY LIGHT LIGHT, PHOTOTHERAPY LBI OHMEDA MEDICAL, PART OF GE MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *