BEUDAMED
    FDA Adverse Event Death Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 19923620 · Received August 6, 2024

    Report

    Report Number
    3005860720-2024-00006
    Event Type
    Death
    Date Received
    August 6, 2024
    Date of Event
    June 23, 2024
    Report Date
    October 8, 2024
    Manufacturer
    GE MEDICAL SYSTEMS ULTRASOUND&PRIMARY CARE DIAGLLC
    Product Code
    FMZ
    PMA / PMN Number
    K101788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE HAS INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A1, A5 AND A6: NO INFORMATION PROVIDED. BLOCK D4 PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.

    Additional Manufacturer Narrative · 0

    THE END USER CONFIRMED THAT EXTERNAL TESTING OF THE INFECTION IDENTIFIED THE SAME STRAIN (LICHTHEIMIA RAMOSA FROM THE ZYGOMYCETE FAMILY ) AS THEIR IN-HOUSE TESTING. THE EXTERNAL TESTS ALSO SHOW THAT THE GE HEALTHCARE GIRAFFE OMNIBED RESULTS WERE ALL NEGATIVE AND THUS UNRELATED TO THE ZYGOMYCETE INFECTION. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, GE HEALTHCARES (GEHC) REVIEW OF THE EVENT DETERMINED THAT THE INFECTION WAS NOT CAUSED OR RELATED TO THE USE OF A GEHC DEVICE. THE GIRAFFE OMNI BED DID NOT CAUSE OR CONTRIBUTE TO THE INFECTION.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT THAT USED A GIRAFFE OMNIBED DEVELOPED A SKIN INFECTION. THE SUSCEPTIBLE PATIENT WAS EXPOSED TO A FUNGUS (LICHTHEIMIA RAMOSA) FROM THE ZYGOMYCETE FAMILY WHICH WAS THE SOURCE OF INFECTION. REPORTEDLY, THE PATIENT INFECTION WAS TREATED WITH AMPHOTERICIN B. IT WAS REPORTED THE PATIENT DIED. 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
    1674095 GIRAFFE OMNIBED INCUBATOR, NEONATAL FMZ GE MEDICAL SYSTEMS ULTRASOUND&PRIMARY CARE DIAGLLC

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Male Death