BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIRAFFE SPOT PT(LED)

    MDR report key: 20378287 · Received October 4, 2024

    Report

    Report Number
    1000122810-2024-00001
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    August 17, 2019
    Report Date
    July 10, 2025
    Manufacturer
    LUMITEX MEDICAL DEVICES, INC.
    Product Code
    LBI
    PMA / PMN Number
    K120820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK G2 REPORT SOURCE OTHER: (B)(6). LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE (GEHC) INVESTIGATION HAS BEEN COMPLETED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE SPECIFIC GIRAFFE BLUE SPOT PT USED DURING PHOTOTHERAPY TREATMENTS WAS NOT IDENTIFIED OR ASSESSED. THE GIRAFFE BLUE SPOT PT HAS LITTLE WAVELENGTH IN EITHER THE IR (HEAT GENERATING) WAVELENGTHS OR THE UV (SUN BURNING) RANGES AND THEREFORE WOULD NOT BE EXPECTED TO RESULT IN A SKIN BURN.

    Description of Event or Problem · 0

    GE HEALTHCARE BECAME AWARE OF A LAWSUIT FILED AGAINST A HOSPITAL AND INDIVIDUAL HEALTH CARE PRACTITIONERS REGARDING THEIR CARE OF A PREMATURELY BORN INFANT USING A GIRAFFE SPOT PT(LED) DEVICE. THE PATIENT EXPERIENCED A REACTION OR PHOTOSENSITIVITY. THE ALLEGATIONS AGAINST THE HOSPITAL AND HCPS STATE THAT PHOTOSENSITIVITY WAS CAUSED DUE TO A COMBINATION OF DYE STUDY PRIOR TO LABOR TO DETERMINE IF THERE WERE AMNIOTIC FLUID LEAKS AND PHOTOTHERAPY PRESCRIBED AFTER BIRTH TO THE PATIENT. THE PATIENT IS REPORTED TO HAVE SUFFERED PARTIAL THICKNESS BURNS, ORIGINALLY CLASSED AS FIRST DEGREE AND SUBSEQUENTLY DETERMINED TO BE SECOND DEGREE, THAT REQUIRED MEDICAL TREATMENT. THE RECORD DOES NOT ALLEGE THAT THE GIRAFFE SPOT PT(LED) DEVICE MALFUNCTIONED. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267386 GIRAFFE SPOT PT(LED) UNIT, NEONATAL PHOTOTHERAPY LBI LUMITEX MEDICAL DEVICES, INC. SEEH11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Female Hospitalization| S| O