BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 25053378 · Received April 30, 2026

    Report

    Report Number
    3013095415-2026-00280
    Event Type
    Death
    Date Received
    April 30, 2026
    Date of Event
    January 27, 2026
    Report Date
    April 30, 2026
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007792
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    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 NEED TO SEND BACK THIS SERIAL NUMBER BACK FOR A SERVICE CHECK DUE TO A PATIENT EVENT WE HAD THAT RESULTED IN THE PATIENT EXPIRING. THE PATIENT WAS NOT ON THE VENTILATOR AT THE TIME OF DEATH, BUT WAS ON IT PRIOR TO, AND WAS REMOVED OFF THE VENT WHEN CPR WAS INITIATED." VENTEC LATER FOLLOWED-UP WITH THE FACILITY'S SENIOR CLINICAL MANAGER (RRT-RCP) WHO PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: "THE PATIENT'S CAREGIVERS HAD REQUESTED RE-EDUCATION ON SUCTIONING. DURING THIS CONVERSATION, THEY ADMITTED TO OUR RT THAT THEY HAD NEITHER SUCTION OR CHANGED THE INNER CANNULA OUT IN THE LAST 6 DAYS, STATING THEY WERE WAITING ON OUR RT TO SHOW THEM AGAIN, DESPITE BEING PROPERLY EDUCATED ON SUCTIONING AND CHANGING INNER CANNULAS (WHICH WE HAVE DOCUMENTED CHECK OFFS WITH THEM FOR). WHEN THEY ATTEMPTED TO SUCTION, THE CATH WOULD NOT PASS. DURING THIS TIME, WE SUSPECT A POSSIBLE MUCUS PLUG WAS DISLODGED. OUR RT REMOVED THE PT FROM THE VENT AND PROCEEDED WITH EMERGENTLY PERFORMING A TRACH CHANGE, BAGGING THE PT, AND STARTING CPR. ONCE THE TRACH WAS CHANGED, RESISTANCE WAS ELIMINATED, AND HE WAS ULTIMATELY ABLE TO VENTILATE THE PT AGAIN. HOWEVER, THE PATIENT WAS UNABLE TO RECOVER. THE VENT WAS NOT PLACED ON THE PT AGAIN AFTER HE WAS INITIALLY TAKEN OFF." THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE. THE PATIENT DID NOT SURVIVE THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461567 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+O+C+S+N+PRO, ENGLISH 00855573007792

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Death