BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE

    MDR report key: 22043820 · Received May 19, 2025

    Report

    Report Number
    22043820
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    May 5, 2025
    Report Date
    May 8, 2025
    Manufacturer
    PULMONX CORP.
    Product Code
    NJK
    UDI-DI
    00811907030225
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON OPENING THE VALVE CARTRIDGE, THE VALVE WAS PARTIALLY DEPLOYED IN CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049547 ZEPHYR ENDOBRONCHIAL VALVE VALVE, PULMONARY NJK PULMONX CORP. EBV-TS-4.0-LP 506945V71 00811907030225

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female