BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEGA INNOVATIONS, INC.

    MDR report key: 17859831 · Received October 3, 2023

    Report

    Report Number
    17859831
    Event Type
    Injury
    Date Received
    October 3, 2023
    Date of Event
    September 12, 2023
    Report Date
    September 29, 2023
    Manufacturer
    CEGA INNOVATIONS, INC.
    Product Code
    FMR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS TRANSFERRED VIA REMUV AIR MAT FROM CARDIAC CATH TABLE TO CART. REMUV MAT WAS THOUGHT TO BE AT REST, AIR SOURCE DISCONNECTED, MAT DEFLATED UNEVENLY, MAT CONTINUED TO MOVE, PATIENT ON MAT CONTINUED TO SLIDE DROPPING ON THE FLOOR. PATIENT SUFFERED FRACTURED RIGHT SEVENTH RIB DUE TO FALL AND EXTENDED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568178 CEGA INNOVATIONS, INC. DEVICE, TRANSFER, PATIENT, MANUAL FMR CEGA INNOVATIONS, INC. MV800 CEGA2021004

    Patients

    Seq Age Sex Outcome Treatment
    1 28835 DA Unknown