BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERO/VENT JR.

    MDR report key: 16929910 · Received May 15, 2023

    Report

    Report Number
    16929910
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    January 11, 2023
    Report Date
    February 28, 2023
    Manufacturer
    MEDI/NUCLEAR CORPORATION, INC.
    Product Code
    IYT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INCORRECT DEVICE KIT WAS USED BECAUSE THE TWO KITS (AV-100HV AND AV-100H) LOOK ALMOST IDENTICAL AND A VERY SIMILAR PRODUCT CODE. USED AV-100HV ON A VENTED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357001 AERO/VENT JR. SYSTEM, REBREATHING, RADIONUCLIDE IYT MEDI/NUCLEAR CORPORATION, INC. AV-100H

    Patients

    Seq Age Sex Outcome Treatment
    1 12775 DA Male Other