BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 23873475 · Received December 22, 2025

    Report

    Report Number
    3013095415-2025-01109
    Event Type
    Death
    Date Received
    December 22, 2025
    Date of Event
    August 23, 2025
    Report Date
    December 22, 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
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: VENTEC WAS ABLE TO OBTAIN THE ELECTRONIC RECORDS (MULTI-VIEW) FROM THE DEVICE FOR ANALYSIS. VENTEC OBSERVED THAT THE DEVICE WAS NOT BEING USED BY THE PATIENT THE DAY PRIOR TO, OR THE DAY OF, THEIR DEATH. THE EVIDENCE SUGGESTED THAT THE PATIENT WAS NOT ON THIS V*HOME VENTILATOR AT THE TIME OF DEATH. VENTEC PROVIDED THIS INFORMATION TO THE DEPUTY CHIEF FORENSIC INVESTIGATOR FOR THEIR INVESTIGATION. THE DEVICE HAS NOT BEEN RETURNED TO VENTEC FOR AN EVALUATION. AS OF THIS REPORT, THE NEW HAMPSHIRE OFFICE OF THE CHIEF MEDICAL EXAMINER HAS BEEN UNABLE TO DETERMINE THE PATIENT'S CAUSE OF DEATH.

    Description of Event or Problem · 0

    THE DEPUTY CHIEF FORENSIC INVESTIGATOR FOR THE MEDICAL EXAMINER'S OFFICE IN (B)(6) CONTACTED VENTEC TO REPORT THAT THEY HAD TAKEN CUSTODY OF A V*HOME VENTILATOR AS PART OF A DEATH INVESTIGATION, AND WERE LOOKING FOR ASSISTANCE WITH DOWNLOADING THE DATA SURROUNDING THE DATE AND TIME OF DEATH. VENTEC CONTACTED THE DEPUTY CHIEF FORENSIC INVESTIGATOR FOR ADDITIONAL INFORMATION AND WAS ADVISED THAT THE PATIENT, A 2-YEAR-OLD FEMALE, HAD DIED ON (B)(6) 2025 BETWEEN 3 AM ¿ 9 AM. AT 9 AM, SHE WAS PRONOUNCED DECEASED. THE MEDICAL EXAMINER ADVISED VENTEC THAT THEY ARE UNSURE OF THE CAUSE OF DEATH AND HOPING THAT OBTAINING DATA FROM THE DEVICE MIGHT ASSIST IN THEIR INVESTIGATION. WHILE THE PATIENT WAS ON THE V*HOME VENTILATOR 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
    2210035 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V*HOME, ENGLISH 00855573007822

    Patients

    Seq Age Sex Outcome Treatment
    1 25 MO Female Death