BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 24464415 · Received February 26, 2026

    Report

    Report Number
    3013095415-2026-00082
    Event Type
    Death
    Date Received
    February 26, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 25, 2026
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007822
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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.

    Additional Manufacturer Narrative · 0

    H6: VENTEC DOWNLOADED THE DEVICE'S ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS. NO ABNORMALITIES WERE OBSERVED AND VENTEC NOTED MULTIPLE INSTANCES WHERE THE DEVICE HAD PREVIOUSLY LOGGED ALARMS APPROPRIATELY. DURING TESTING, VENTEC FOUND THAT ALL AUDIBLE AND VISUAL ALARMS FUNCTIONED AS EXPECTED. VENTEC ALSO COMPLETED A PRE-USE TEST USING THE PATIENT'S SETTINGS WHICH PASSED. PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. VENTEC WAS UNABLE TO CONFIRM ANY ISSUES WITH THE DEVICE WHICH MAY HAVE CONTRIBUTED TO THE PATIENT'S OUTCOME. THERE WAS NO FAILURE OF THE DEVICE.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO VENTEC VIA EMAIL: "ON (B)(6) 2026 PER BEAUMONT RT WE RECEIVED A CALL TO OUR BEAUMONT OFFICE BRANCH FROM THE MOTHER THAT THE PATIENT HAS PASSED AWAY. SHE CALLED AT 3:07PM AND STATED PATIENT HAS PASSED AWAY 2 HOURS AGO. THE NEXT DAY (B)(6) 2026 HOME CARE NURSE STATED THAT THE VENTILATOR DID NOT ALARM DURING THE EVENT AND RT ASKED HER TO EXPLAIN. SHE STATED THAT SHE WAS ABOUT TO GIVE HER A BREATHING TREATMENT WHEN SHE NOTICED THAT SHE WAS NOT WAKING UP. SHE SAID THAT SHE WENT OVER AND CALLED HER NAME AND HER EYES CRACKED OPEN. SHE SAID HER COLOR STARTED TO LOOK BAD. SHE SAID SOMETHING IS WRONG. SHE STATED WHEN SHE STARTED COMPRESSIONS THE VENTILATOR STARTED ALARMING. NURSE ALSO STATED THAT TO BEAUMONT RT THAT PATIENT TOLD HER MOTHER SEVERAL DAYS BEFORE THAT SHE WOULD NOT BE HERE MUCH LONGER. NURSE ALSO STATED MOM AND HER BOTH NOTICED PATIENT WAS NOT THE SAME SINCE HER LAST HOSPITAL VISIT. HOMECARE NURSE STATED SHE CALLED 911 AND THEY TOOK PATIENT TO HOSPITAL AND SHE WAS DECLARED DECEASED." VENTEC LATER FOLLOWED-UP WITH THE DME WHO REPORTED THE EVENT. THE DME ADVISED, "THE VENT DID NOT ALARM FROM WHAT WE SAW ON THE DOWNLOAD AS THE PATIENT WAS STILL BREATHING IT WAS JUST SHALLOW, CAUSE SHE HAS ALS." BASED ON THE INFORMATION PROVIDED, IT'S REASONABLE TO CONCLUDE THAT THE DEVICE DID NOT ALARM BECAUSE THE PATIENT WAS STILL BREATHING (ALBEIT SHALLOW). THERE HAS BEEN NO ALLEGATION OF A DEVICE MALFUNCTION THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S OUTCOME. NO FURTHER DETAILS ABOUT THE EVENT WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526089 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V*HOME, ENGLISH 00855573007822

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Death