BEUDAMED
    FDA Adverse Event Death Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 8451058 · Received March 26, 2019

    Report

    Report Number
    1121732-2019-00003
    Event Type
    Death
    Date Received
    March 26, 2019
    Date of Event
    February 27, 2019
    Report Date
    May 17, 2019
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    PMA / PMN Number
    K152814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE PROVIDED. THE PATIENT WAS A (B)(6) WEEK NEONATE THAT WAS (B)(6) DAY OLD. THE PATIENT WAS EXTREMELY PREMATURE, WITH UNDERLYING CONDITIONS. WHEN THE PATIENT WAS ADMITTED TO THE GIRAFFE OMNIBED THE HOOD FAILED TO RAISE UP. THE PATIENT WAS UNSTABLE AND THE HEALTHCARE PROVIDER DECIDED TO KEEP THE PATIENT IN THE GIRAFFE OMNIBED WITH THE HOOD DOWN USING INCUBATOR MODE TO MAINTAIN THE DESIRED TEMPERATURE INSTEAD OF MAINTAINING TEMPERATURE VIA RADIANT HEAT WITH THE HOOD UP. THE HEALTHCARE PROVIDER MAINTAINED THE DESIRED TEMPERATURE VIA INCUBATOR MODE, BUT THE PATIENT PASSED AWAY. THE NEONATAL INTENSIVE CARE UNIT NURSE MANAGER INFORMED GE HEALTHCARE (GEHC) THAT THE BED DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. THE INCUBATOR IS OWNED BY (B)(6) AND WAS BEING RENTED BY (B)(6) HOSPITAL. (B)(6), WAS NOTIFIED THAT THE CANOPY STOPPED WORKING. (B)(6) ADVISED GEHC THAT "THE UNIT HAS BEEN TESTED AND IT WAS FOUND THAT THE CANOPY IS NOT RAISING FULLY WHICH WILL CAUSE THE (RADIANT) HEATER NOT TO ENGAGE." GEHC PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. POSSIBLE CAUSES FOR THE CANOPY NOT MOVING UP COULD BE - BELT, CABLE HARNESS, CANOPY MOTOR, ELECTRICAL COMPONENT, FOOT SWITCH, LOOSE CONNECTION, MEMBRANE SWITCH, RAIL/CANOPY LIFT. (B)(6) DOES NOT HAVE A SERVICE AGREEMENT WITH GEHC FOR THE SERVICE/MAINTENANCE OF THE GIRAFFE OMNIBED. (B)(6) USES THEIR OWN REPAIR SHOP FOR SERVICE AND MAINTENANCE OF THE UNIT. (B)(6) HAS NOT MADE A REQUEST FOR GEHC TO INSPECT OR TEST THE GIRAFFE OMNIBED. THEREFORE, THE ROOT CAUSE FOR THIS INVESTIGATION IS "UNDETERMINED"?.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE (B)(4) INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. THE CUSTOMER CONTACT REPORTED THERE IS NO PATIENT INFORMATION AVAILABLE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE PATIENT DIED DURING USE OF THIS DEVICE. IT WAS ALSO REPORTED THAT THE HEATER ON THE DEVICE WAS NOT WORKING. THE HOSPITAL DOES NOT BELIEVE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245093 GIRAFFE OMNIBED NEONATAL INCUBATOR FMZ OHMEDA MEDICAL 6650-0004-901

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Death