BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 21810974 · Received April 9, 2025

    Report

    Report Number
    3013095415-2025-00305
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 9, 2025
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPON RECEIPT OF THE DEVICE, VENTEC DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS AND OBSERVED THAT THE DEVICE HAD PREVIOUSLY LOGGED MULTIPLE REBOOT EVENTS. THE DEVICE WAS THEN EVALUATED BY VENTEC WHERE THE REPORTED ISSUE OF IT REBOOTING BY ITSELF COULD NOT BE DUPLICATED. PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. AS A PRECAUTION, VENTEC REPLACED THE CONTROL BOARD, INTERNAL FLOW TRANSDUCER (IFT) AND EXHALATION CONTROL MODULE (ECM). THE CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON RECEIPT OF THE DEVICE, VENTEC DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS AND OBSERVED THAT THE DEVICE HAD PREVIOUSLY LOGGED MULTIPLE REBOOT EVENTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815311 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+O+C+S+N+PRO, ENGLISH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown