BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIO ADULT

    MDR report key: 21750879 · Received April 2, 2025

    Report

    Report Number
    9616791-2025-00002
    Event Type
    Malfunction
    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
    PMA / PMN Number
    K142086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE TWO MEDICINAL DEVICES INVOLVED IN THIS REPORT. ONE MEDICAL DEVICE ONLY REMAIN IN USER HANDS, WHICH HAS BEEN REQUESTED TO BE RETURNED TO MANUFACTURER SITE TO PERFORM AN ENGINEERING INVESTIGATION.

    Description of Event or Problem · 0

    COMPLAINT DESCRIPTION FROM CUSTOMER ON MARCH 30 2025: "PATIENT WAS IN CARDIAC ARREST WITH CPR BEING PERFORMED. CREW ARRIVED, 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 EMT. 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
    744574 NIO ADULT INTRAOSSEOUS ACCESS DEVICE FOR ADULTS FMI WAISMED LTD NIO-A 2440043 07290008325059

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female