BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIRAFFE OMNIBED CARESTATION

    MDR report key: 9148392 · Received October 2, 2019

    Report

    Report Number
    2112667-2019-00976
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    August 23, 2019
    Report Date
    November 20, 2019
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    FMZ
    PMA / PMN Number
    K123309
    Removal / Correction Number
    FMI32070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT DATE: THE INCIDENT DATE ON THE INITIAL MDR WAS (B)(6) 2019 AND IS INCORRECT. THE CORRECT INCIDENT DATE IS (B)(6) 2019. ON (B)(6) 2019, GE HEALTHCARE PERSONNEL MET WITH HOSPITAL PERSONNEL TO INVESTIGATE THE ISSUE AND INSPECT THE UNIT INVOLVED WITH THIS EVENT. THE HOSPITAL WAS USING A PHOTOTHERAPY DEVICE ON THE INFANT WITH THE POWER CORD POSITIONED THROUGH THE SOUTH WALL GROMMET. DURING THE REVIEW OF THE DEVICE BY GE HEALTHCARE, IT WAS ALSO DISCOVERED THAT THE NORTHWEST LATCH WAS NOT PERFORMING ACCORDING TO SPECIFICATIONS WHICH COULD RESULT IN THE NORTHWEST LATCH NOT LATCHING AS EXPECTED IF THE WEST WALL WAS PUSHED CLOSED WITHOUT SQUEEZING BOTH LATCHES. IT IS BELIEVED THAT THE SOUTHWEST LATCH OF THE WEST WALL BECAME UNLATCHED FOLLOWING FORCEFUL MANIPULATION OF A PHOTO THERAPY DEVICE POWER CORD AND THE NORTHWEST LATCH WAS NEVER PROPERLY LATCHED, WHICH ALLOWED THE WEST WALL TO FALL OPEN. DUE TO THE REDUNDANCY OF THE DESIGN, A SINGLE LATCH MALFUNCTION CANNOT ALONE LEAD TO A POTENTIAL FOR A SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. CUSTOMER CONTACT DECLINED TO PROVIDE PATIENT IDENTIFIER. ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. "AT THIS TIME THE NURSE AND STAFF WENT INTO EMERGENCY RESPONSE PROTOCOLS TO ADDRESS THE INFANT. A CT SCAN AND SKELETAL SURVEY WAS PERFORMED. THE NURSING DIRECTOR STATED THE PATIENT SUSTAINED A NON-DISPLACED PARIETAL FRACTURE." DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE HEALTHCARE THAT A NICU NURSE WAS WALKING BY AND HEARD A BABY CRYING. SHE WENT IN THE NICU AND FOUND THE INFANT ON ITS BACK ON THE FLOOR ON THE LEFT SIDE OF THE BED AND THE LEFT RAIL (SIDE PANEL) WAS DOWN. THE BABY WAS PLACED BACK IN THE SAME WARMER BRIEFLY AND THEN MOVED TO ANOTHER WARMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940954 GIRAFFE OMNIBED CARESTATION INCUBATOR, NEONATAL FMZ DATEX-OHMEDA, INC. 2082844-001

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Other