BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 12257158 · Received July 31, 2021

    Report

    Report Number
    3005860720-2021-00002
    Event Type
    Injury
    Date Received
    July 31, 2021
    Date of Event
    June 24, 2021
    Report Date
    September 7, 2021
    Manufacturer
    GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAG
    Product Code
    FMZ
    PMA / PMN Number
    K101788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE (GEHC) PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. DEVICE WARNING STICKERS WERE IN PLACE FOR THE DEVICE, SPRINGS ON THE LATCHES WERE FUNCTIONAL, ALL LATCHES WERE INSPECTED AND VERIFIED TO BE SECURE WHEN FULLY INSERTED. THE INVESTIGATION DETERMINED THAT THE DEVICE FUNCTIONED AS INTENDED, DID NOT MALFUNCTION, AND MET ALL SPECIFICATIONS. THE CUSTOMER DID NOT PROVIDE ADDITIONAL DETAILS AFTER MULTIPLE ATTEMPTS BY GEHC. THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARES INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED TO GE HEALTHCARE (GEHC) AN INCIDENT ON A GIRAFFE OMNIBED ON (B)(6) 2021 WITH A 6-DAY OLD PATIENT. THE PATIENT WAS DISCOVERED ON THE FLOOR BY THE HOSPITAL STAFF. IT WAS REPORTED THAT THE PATIENT IS STABLE AND HAS BEEN DISCHARGED FROM THE HOSPITAL. A GEHC EXAMINATION OF THE DEVICE DETERMINED THAT IT WAS FULLY FUNCTIONING AS DESIGNED, INCLUDING THE DOOR LATCHES. GEHC WILL SUBMIT A FOLLOW-UP REPORT WHEN THE FORMAL INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154128 GIRAFFE OMNIBED INCUBATOR, NEONATAL FMZ GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAG 6650-0004-901

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Other