BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE SYSTEM

    MDR report key: 23110286 · Received September 22, 2025

    Report

    Report Number
    MW5176316
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Report Date
    July 7, 2025
    Manufacturer
    PULMONX CORP.
    Product Code
    NJK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REPLACE THIS NON-(B)(6) DEVICE FOR UNSPECIFIED REASONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201682 ZEPHYR ENDOBRONCHIAL VALVE SYSTEM VALVE, PULMONARY NJK PULMONX CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown