BEUDAMED
    FDA Adverse Event Death Summary report: N

    NIO ADULT

    MDR report key: 21756448 · Received April 2, 2025

    Report

    Report Number
    3008258694-2025-00001
    Event Type
    Death
    Date Received
    April 2, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 2, 2025
    Manufacturer
    WAISMED LTD.
    Product Code
    FMI
    UDI-DI
    07290008325059
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS IN CARDIAC ARREST WITH CPR BEING PERFORMED. CREW ARRIVED AND TOOK OVER CPR. IV WAS ATTEMPTED AND FAILED. NIO WAS BROUGHT OUT, SITE LOCATED AND WHEN WE SPUN THE TOP ON THE NIO TO UNLOCK IT, IT WAS TIGHT TO TURN. PRESSURE PLACED WITH DOMINANT HAND, OTHER HAND STABILIZING NIO. NIO DID NOT DEPLOY, SECOND CREWMEMBER ATTEMPTED TO DEPLOY IT AND IT DID NOT WORK. SECOND NIO WAS BROUGHT OUT AND THE SAME THING HAPPENED. TOP WAS TIGHT TO SPIN AND IT DID NOT DEPLOY FOR EITHER THE RN OR AEMT. MANUAL IO WAS PLACED IN THIS PATIENT FIRST ATTEMPT. CPR CONTINUED. PATIENT DIED. ONE OF THE NIO THAT DID NOT DEPLOY WAS BROUGHT BACK TO THE STATION AND IS CURRENTLY BEING SENT BACK WITH THE PROVIDED SHIPPING LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264386 NIO ADULT INTRAOSSEOUS ACCESS DEVICE FOR ADULTS FMI WAISMED LTD. NIO-A 2440043 07290008325059

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death