BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIRAFFE INCUBATOR

    MDR report key: 22699944 · Received August 4, 2025

    Report

    Report Number
    2112667-2025-06259
    Event Type
    Injury
    Date Received
    August 4, 2025
    Date of Event
    June 26, 2025
    Report Date
    October 28, 2025
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    FMZ
    PMA / PMN Number
    K101788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A1, A3, 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: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARES (GEHC) INVESTIGATION HAS BEEN COMPLETED AND CONFIRMED THAT THE DEVICE OPERATED AS INTENDED AND MET ALL PERFORMANCE SPECIFICATIONS. A GE HEALTHCARE FIELD ENGINEER CONDUCTED AN ON-SITE INSPECTION AT THE CUSTOMER LOCATION AND VERIFIED THE FOLLOWING: ALL COMPONENTS WERE INTACT AND PROPERLY ASSEMBLED. PORTHOLE LATCHES WERE FUNCTIONAL. PORTHOLE DOORS OPENED AND CLOSED AS DESIGNED. NO DEVICE MALFUNCTION WAS IDENTIFIED. FOLLOWING THE INITIAL INSPECTION, GE HEALTHCARE COLLABORATED WITH THE HOSPITAL TO OBTAIN ADDITIONAL INFORMATION. DURING THE INCIDENT, THE UNIT WAS COVERED WITH A NON-GE HEALTHCARE CANOPY COVER. THE GEHC FIELD ENGINEER REPLICATED THE CONDITIONS USING THE SAME TYPE OF COVER AND AN UNLATCHED PORTHOLE DOOR. THE EVALUATION REVEALED: THE CANOPY COVERS WEIGHT IMPEDED THE FULL OPENING OF THE PORTHOLE DOOR. VISUAL DETECTION OF AN UNLATCHED DOOR WAS DIFFICULT UNDER THESE CONDITIONS. THE HOSPITAL ACKNOWLEDGED THAT THE CANOPY COVER MAY HAVE OBSTRUCTED VISUAL CONFIRMATION OF PROPER LATCHING. AS REPORTED BY THE HOSPITAL, THE USE OF THE NON-GE HEALTHCARE CANOPY COVER COULD HAVE HINDERED THE VISUAL INSPECTION OF THE CORRECT CLOSING OF THE PORTHOLES AND THAT BASED ON THE EVIDENCE OF RETURNING TO FIND THE PORTHOLE OPEN, THE HOSPITAL ALSO DETERMINED THAT IT APPEARED THE LATCH MAY NOT HAVE BEEN PROPERLY CLOSED. THERE WERE NO MALFUNCTIONS WITH THE PORTHOLE DOORS OR LATCHES. THE DOOR COULD NOT HAVE OPENED WITHOUT MANUAL ROTATION OF THE LATCH MECHANISM. BASED ON THE ABOVE IT WAS DETERMINED THAT THERE WERE NO MALFUNCTIONS WITH THE PORTHOLE DOORS OR LATCHES, AND THAT THERE WAS NO POSSIBILITY THE PORTHOLE DOOR COULD HAVE OPENED WITHOUT MANUAL INTERVENTION WITH ROTATING THE EXISTING LATCH MECHANISM ON THE DEVICE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT FELL FROM A GIRAFFE INCUBATOR. IT WAS ALLEGED THAT THE PATIENT WAS FOUND ON THE FLOOR WITH THE OXYGEN SATURATION SENSOR STILL ATTACHED TO THE RIGHT FOOT. AFTER THE INCIDENT, THE PATIENT RECEIVED A CLINICAL AND NEUROLOGICAL EXAMINATION, X-RAY OF THE SPINE, LIMBS, AND CHEST, AND A BRAIN MRI WHICH DID NOT IDENTIFY ANY INJURY. 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
    202982 GIRAFFE INCUBATOR INCUBATOR, NEONATAL FMZ DATEX-OHMEDA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 DA Unknown Other