BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 24760927 · Received April 1, 2026

    Report

    Report Number
    3013095415-2026-00191
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 1, 2026
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE INITIAL REPORTER DID NOT PROVIDE VENTEC WITH THE DEVICE'S SERIAL NUMBER. AS A RESULT, SECTION D4 (MODEL #, CATALOG #, SERIAL #, AND UDI NUMBER) ARE ALL "UNKNOWN", AND SECTION H4 (DEVICE MANUFACTURING DATE) SHALL BE LEFT BLANK. IN THE EVENT THAT ADDITIONAL INFORMATION IS RECEIVED, VENTEC WILL SUBMIT A FOLLOW-UP REPORT AS DEFINED BY 21 CFR 803.56. THE INITIAL REPORTER ADVISED THAT THEY FELT THAT THE DEVICE'S FILTERS WERE EASILY SOILED, AND THAT THEY HAD TO BE CHANGED FREQUENTLY. A VENTEC LIFE SYSTEMS, INC. D/B/A REACT HEALTH PRODUCT SUPPORT SPECIALIST ADVISED THE INITIAL REPORTER ON THE IMPORTANCE OF COMPLETING THE PRE-USE TEST (PUT). THE VOCSN CLINICAL AND TECHNICAL MANUAL STATES THE FOLLOWING [P. 50]: "THE VOCSN PRE-USE TEST CALCULATES THE RESISTANCE AND LEAK OF THE VENTEC ONE-CIRCUIT. BASED ON THESE CALCULATIONS, VOCSN VERIFIES THE INTEGRITY OF THE VENTEC ONE-CIRCUIT, AND ALSO IMPROVES THE ACCURACY OF THERAPY DELIVERED DURING VENTILATION." "IT IS RECOMMENDED TO RUN A PRE-USE TEST EACH TIME THE VENTEC ONE-CIRCUIT OR ITS CONFIGURATION IS CHANGED OR IN ANY WAY MODIFIED BEFORE INITIATING THERAPY." TO THE BEST OF VENTEC'S KNOWLEDGE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT THE DEVICE'S TIDAL VOLUME WAS ZERO. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811655 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown