BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 23067619 · Received September 16, 2025

    Report

    Report Number
    3013095415-2025-00821
    Event Type
    Death
    Date Received
    September 16, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 16, 2025
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007822
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: VENTEC HAS REQUESTED THAT THE DEVICE BE RETURNED FOR AN EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 0

    H6: UPON RECEIPT OF THE DEVICE VENTEC DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS. THE VENTEC VP OF ENGINEERING REVIEWED THE LOGS AND CONFIRMED THE PRESENCE OF PATIENT CIRCUIT DISCONNECT ALARMS THE EVENING OF (B)(6) 2025 AND MORNING OF (B)(6) 2025, WHICH IS BELIEVED TO BE THE MORNING OF THE REPORTED EVENT AS IT WAS THE LAST RECORDED DAY PRIOR TO THE VENTILATOR BEING TURNED OFF. MULTIPLE ATTEMPTS WERE MADE BY VENTEC TO CONTACT THE INITIAL REPORTER IN ORDER TO CONFIRM THE DATE OF EVENT AND BRAND/SIZE OF THE TRACH THE PATIENT WAS USING, HOWEVER, NO RESPONSE HAS BEEN RECEIVED. VENTEC THEN WENT ON TO REVIEW THE CUSTOMER'S SETTINGS, AND FOUND THAT THE LOW MINUTE VOLUME AND LOW INSPIRATORY ALARM SETTING WERE TURNED OFF, AND THAT THE PATIENT CIRCUIT DISCONNECT ALARM WAS SET TO ALARM AFTER 2 BREATHS. IT WAS ALSO OBSERVED THAT THE ALARM VOLUME WAS SET TO LOW. VENTEC THEN TESTED THE DEVICE ON THE SERVICE BENCH, WHERE THE PATIENT CIRCUIT DISCONNECT ALARM PERFORMED AS EXPECTED. IT WAS ALSO NOTED THAT THE DEVICE'S PIEZO ALARM WAS ALSO FUNCTIONING PROPERLY. WHEN VENTEC TESTED THE DEVICE ON THE CUSTOMER'S PRIMARY SETTINGS, THE DEVICE WAS OBSERVED TO BE VENTILATING NORMALLY WITH ALL MEASUREMENTS READING WITHIN SPECIFICATIONS. THE DEVICE WAS ALSO TESTED ON PRESET 2 SETTINGS, WHERE IT CONTINUED TO PERFORM AS EXPECTED. THE REPORTED ISSUE OF THE DEVICE'S ALARM NOT FUNCTIONING AS EXPECTED COULD NOT BE DUPLICATED OR CONFIRMED. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT A PEDIATRIC PATIENT'S TRACH TUBE BECAME DETACHED FROM THEIR DEVICE, AND THAT THE DEVICE DID NOT PROVIDE AN ALARM. THE PATIENT DID NOT SURVIVE THE REPORTED EVENT. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT HAVE BEEN PROVIDED. VENTEC HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE INITIAL REPORTER IN AN EFFORT TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE HAS BEEN RECEIVED. ADDITIONALLY, THE DATE OF THE PATIENT'S DEATH WAS NOT CONFIRMED, THEREFORE SECTION B2, DATE OF DEATH, SHALL REMAIN BLANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269059 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V*HOME, ENGLISH 00855573007822

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Male Death