BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 14151884 · Received April 19, 2022

    Report

    Report Number
    3005860720-2022-00004
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    March 4, 2022
    Report Date
    July 22, 2022
    Manufacturer
    GE MEDICAL SYSTEMS ULTRASOUND&PRIMARY CARE DIAGLLC
    Product Code
    FMZ
    PMA / PMN Number
    K101788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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. PATIENT IDENTIFIER, SEX, ETHNICITY, AND RACE INFORMATION NOT PROVIDED. LEGAL MANUFACTURER: HCS (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE FIELD ENGINEER AND ONSITE BIOMED TEAM 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 (EAST) DID NOT PROPERLY LATCH IT AFTER PATIENT CARE. THE USER THAT WAS PERFORMING THE LINEN CHANGE DID NOT WALK TO THE OTHER SIDE OF THE DEVICE (EAST) TO CHECK THE STATUS OF THOSE BEDSIDE PANEL LATCHES PRIOR TO INITIATING PATIENT CARE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT FALL WHEN A NURSE MOVED THE PATIENT FROM ONE SIDE OF THE DEVICE TO THE OTHER WHILE CHANGING LINEN DURING USE OF THE GIRAFFE OMNIBED. AN X-RAY WAS COMPLETED AND WAS NEGATIVE FOR INJURIES. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY IN STABLE CONDITION. A GE FIELD ENGINEER AND THE HOSPITAL BIOMED TEAM EXAMINED THE UNIT AFTER THE INCIDENT AND NO DEVICE DAMAGE OR DEFECTS WERE IDENTIFIED. 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
    1272197 GIRAFFE OMNIBED INCUBATOR, NEONATAL FMZ GE MEDICAL SYSTEMS ULTRASOUND&PRIMARY CARE DIAGLLC 6650-0004-901

    Patients

    Seq Age Sex Outcome Treatment
    1 34 WK Unknown