BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 23587155 · Received November 18, 2025

    Report

    Report Number
    3013095415-2025-00999
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    August 15, 2025
    Report Date
    November 18, 2025
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007877
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPON RECEIPT OF THE DEVICE, VENTEC DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS WHERE IT WAS OBSERVED THAT THE DEVICE HAD PROVIDED LOWER THAN EXPECTED EXHALED TIDAL VOLUME (VTE) LEVELS. VENTEC REPLACED THE INTERNAL FLOW TRANSDUCER (IFT) TO RESOLVE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS THEN CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THE CAUSE OF THE REPORTED ISSUE TO BE THE IFT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. DURING THE DEVICE'S EVALUATION, VENTEC DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS WHERE IT WAS OBSERVED THAT THE DEVICE HAD PROVIDED LOWER THAN EXPECTED EXHALED TIDAL VOLUME (VTE) LEVELS. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810353 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+PRO, ENGLISH 00855573007877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown