BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTA/VENT

    MDR report key: 23224175 · Received October 6, 2025

    Report

    Report Number
    MW5176971
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 25, 2025
    Report Date
    October 2, 2025
    Manufacturer
    MEDI NUCLEAR CORP., INC.
    Product Code
    IYT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    KITS WERE FAILING THE SALINE TEST OR SIMPLY AEROSOLIZING POORLY. PT CODE: 4582. DEVICE CODE: 1266. REF REPORT: MW5176972.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2574405 INSTA/VENT SYSTEM, REBREATHING, RADIONUCLIDE IYT MEDI NUCLEAR CORP., INC. 25MN25265

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown