BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 24264676 · Received February 4, 2026

    Report

    Report Number
    3013095415-2026-00043
    Event Type
    Death
    Date Received
    February 4, 2026
    Date of Event
    January 4, 2026
    Report Date
    February 4, 2026
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007877
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE DEVICE WAS RECEIVED BY VENTEC FOR AN EVALUATION. VENTEC DOWNLOADED THE DEVICE'S ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS WHERE IT WAS OBSERVED THAT IT HAD LOGGED MULTIPLE LOW INSPIRATORY PRESSURE, PATIENT CIRCUIT DISCONNECT, LOW MINUTE VOLUME AND HIGH BREATH RATE ALARMS DURING THE REPORTED EVENT. VENTEC ALSO OBSERVED THAT THE ALARM LOG HAD BEEN CLEARED APPROXIMATELY 40 TIMES DURING THE EVENT. PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. NO ISSUES WITH THE DEVICE OR ITS ALARM SYSTEM WERE OBSERVED. VENTEC CONTACTED THE INITIAL REPORTER AND PROVIDED HER WITH THE INVESTIGATION RESULTS, INCLUDING PROVIDING HER WITH THE LIST OF ALARMS THAT OCCURRED DURING THE REPORTED EVENT. VENTEC ALSO EDUCATED THE INITIAL REPORTER ON HOW TO UPLOAD THE DEVICE'S SYSTEM LOGS INTO MULTIVIEW, AS WELL AS THE PROCESS OF HOW TO CLEAR THE LOGS. THE INVESTIGATION DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS USER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT A PATIENT CODED WHILE ON THE VOCSN. A MEDICAL DOCTOR WAS REPORTEDLY WALKING PAST THE PATIENT'S ROOM WHEN THEY HEARD THE VOCSN ALARMING. THE DOCTOR CONTINUALLY CLEARED THE ALARMS AND BEGAN TO ATTEMPT TROUBLESHOOTING THE DEVICE. APPROXIMATELY 1 MINUTE AFTER THE ALARMS BEGAN, THE PATIENT CODED AND LIFESAVING MEASURES WERE TAKEN. IT WAS DURING THIS TIME THAT PERSONNEL NOTICED THAT THE PATIENT BREATHING CIRCUIT HAD BECOME DISCONNECTED AT THE ENDOTRACHEAL (ET) TUBE. THE INITIAL REPORTER ESTIMATED THAT THE PATIENT HAD BEEN DISCONNECTED FOR APPROXIMATELY 3 MINUTES. THE PATIENT WAS RESUSCITATED, BUT PASSED AWAY THE FOLLOWING DAY. THE INITIAL REPORTER STATED THAT SHE WAS NOT ALLEGING AN ISSUE WITH THE DEVICE NOT ALARMING, AS IT CLEARLY WAS (AND HOW PERSONNEL WERE ALERTED IN THE FIRST PLACE). THE INITIAL REPORTER ADVISED THAT THE ALARMS HAD BEEN CLEARED DURING THE EVENT, SO SHE COULD ONLY SPECULATE WHAT HAD OCCURRED. THE INITIAL REPORTER REQUESTED ASSISTANCE FROM VENTEC WITH OBTAINING THE ALARMS FROM THE DEVICE'S ELECTRONIC RECORDS (SYSTEM LOGS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316984 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+PRO, ENGLISH 00855573007877

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Death