BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIRAFFE OMNIBED CARESTATION

    MDR report key: 14687024 · Received June 14, 2022

    Report

    Report Number
    2112667-2022-01562
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    May 5, 2022
    Report Date
    August 5, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    FMT
    PMA / PMN Number
    K152814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. LEGAL MANUFACTURER: HCS (B)(4).

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE FIELD ENGINEER PERFORMED AN INSPECTION ON ALL THE PATIENT DOORS WITH NO DEFECTS FOUND. ALL SIDE PANEL DOORS, LATCHES AND LOCKING MECHANISMS WERE IN PROPER WORKING CONDITION ALONG WITH THE APPROPRIATE WARNING LABEL STICKERS FOR EACH DOOR. THERE WAS NO PRODUCT MALFUNCTION IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, POTENTIAL ROOT CAUSES ARE: - THE USER THAT CLOSED THE FAR PANEL (WEST) DID NOT PROPERLY LATCH IT AFTER PATIENT CARE. - THE USER THAT WAS FEEDING THE PATIENT DID NOT WALK TO THE OTHER SIDE OF THE DEVICE (WEST) TO CHECK THE STATUS OF THOSE BEDSIDE PANEL LATCHES PRIOR TO INITIATING PATIENT CARE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED AN INFANT FELL FROM THE GIRAFFE OMNIBED CARESTATION. THE SIDE PANEL OPPOSITE OF THE SIDE PANEL THAT WAS USED FOR FEEDING PRIOR TO THE INCIDENT AND THE SIDE FROM WHICH AN IV WAS STARTED PRIOR TO FEEDING WAS FOUND OPEN. THE SIDE THAT WAS USED FOR FEEDING (THROUGH PORTHOLES WITH CANOPY RAISED) WAS FOUND TO BE SECURE. A CAT SCAN WAS PERFORMED AND WAS NORMAL. THE INFANT REQUIRED NO ADDITIONAL TREATMENT AND WAS DISCHARGED HOME. 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
    1476347 GIRAFFE OMNIBED CARESTATION INCUBATOR, NEONATAL FMT DATEX-OHMEDA, INC. 2082844-001

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Unknown Other