BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 23831514 · Received December 17, 2025

    Report

    Report Number
    3013095415-2025-01090
    Event Type
    Death
    Date Received
    December 17, 2025
    Date of Event
    November 1, 2025
    Report Date
    December 17, 2025
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007822
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE DEVICE WAS EVALUATED BY VENTEC WHERE PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. VENTEC DOWNLOADED THE DEVICE'S ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS, BUT NO ABNORMALITIES WERE OBSERVED. VENTEC DID NOT OBSERVE ANY ISSUES WITH THE DEVICE WHICH MAY HAVE CONTRIBUTED TO THE PATIENT'S OUTCOME.

    Additional Manufacturer Narrative · 0

    H6: VENTEC WILL PERFORM AN EVALUATION OF THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO VENTEC VIA EMAIL: "WE WERE NOTIFIED THAT THE DEVICE WAS IN USE ON A PATIENT THAT UNFORTUNATELY PASSED. THE CUSTOMER DID NOT STATE THAT THERE WERE ANY FAILURES ASSOCIATED WITH THE VENTILATOR BUT HAS REQUESTED AN INSPECTION." WHILE THE PATIENT WAS ON THE DEVICE AT THE TIME OF DEATH, THERE HAS BEEN NO ALLEGATION OF A DEVICE MALFUNCTION, NOR WAS IT ALLEGED THAT THE DEVICE USE CAUSED OR CONTRIBUTED TO THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186575 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V*HOME, ENGLISH 00855573007822

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Female Death