BEUDAMED
    FDA Adverse Event Other Summary report: N

    GIRAFFE INCUBATOR

    MDR report key: 539238 · Received August 16, 2004

    Report

    Report Number
    1121732-2004-00009
    Event Type
    Other
    Date Received
    August 16, 2004
    Date of Event
    July 18, 2004
    Report Date
    August 16, 2004
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TRIPLET INFANTS WERE CO-BEDDED IN A GIRAFFE INCUBATOR. A NURSE OPENED ONE OF THE PORTHOLE DOORS TO CONNECT A FEEDING TUBE AND THEN CLOSED THE DOOR. THE NURSE MOVED TO THE OPPOSITE SIDE OF THE UNIT AND HEARD A CLICK SOUND AND A LOUD CRY FROM ONE OF THE INFANTS. THE NURSE IMMEDIATELY RETURNED TO THE OTHER SIDE OF THE UNIT AND FOUND THAT ONE OF THE INFANTS HAD FALLEN OUT OF ONE OF THE PORTHOLE DOORS AND WAS SUSPENDED APPROX ONE FOOT BELOW THE BOTTOM RIM OF THE DOOR BY AN OXYGEN MONITOR CABLE WHICH WAS WRAPPED AROUND ONE OF THE INFANT'S ANKLES. THE INFANT WAS ASSESSED FOR ANY POSSIBLE INJURIES AND WAS RETURNED TO THE UNIT. THERE WAS NO REPORTED INJURY TO THE INFANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE INCUBATOR INFANT THERMOREGULATION FMZ OHMEDA MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other