BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTAVENT PLUS KIT

    MDR report key: 20532362 · Received October 25, 2024

    Report

    Report Number
    20532362
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    October 3, 2024
    Report Date
    October 10, 2024
    Manufacturer
    MEDI NUCLEAR CORP., INC.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS HAVING A LUNG VENTILATION SCAN IN NUCLEAR MEDICINE. THE INSTAVENT PLUS KIT THAT A PATIENT INHALES THROUGH APPEARS TO HAVE BEEN DEFECTIVE. THE RADIOACTIVE DOSE WAS ADMINISTERED BUT DID NOT ENTER THE PATIENT VIA THE INSTAVENT PLUS KIT. WHEN THE SCAN WAS DONE, NOTHING WAS VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945191 INSTAVENT PLUS KIT NEBULIZER (DIRECT PATIENT INTERFACE) CAF MEDI NUCLEAR CORP., INC. IV-600P 24MN446

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male