BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE

    MDR report key: 22728371 · Received August 6, 2025

    Report

    Report Number
    22728371
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 16, 2025
    Report Date
    July 28, 2025
    Manufacturer
    PULMONX, CORP
    Product Code
    NJK
    UDI-DI
    00811907030423
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VALVE DID NOT LOAD ONTO THE DEPLOYER PROPERLY. STUCK OUT OF DEPLOYER HALF DEPLOYED. UNABLE TO USE VALVE. DID THIS FOR 2 VALVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533257 ZEPHYR ENDOBRONCHIAL VALVE VALVE, PULMONARY NJK PULMONX, CORP EBV-TS-5.5-LP 507301V70 00811907030423

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male