BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 19852399 · Received July 29, 2024

    Report

    Report Number
    3013095415-2024-00558
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 1, 2024
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE DEVICE WAS EVALUATED BY VENTEC. VENTEC WAS UNABLE TO CONFIRM ANY ISSUES WITH THE DEVICE WHICH MAY HAVE CONTRIBUTED TO THE PATIENT'S ALLEGED DESATURATION. PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    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 PATIENT EVENT WAS REPORTED TO VENTEC VIA EMAIL BY A REACT HEALTH EMPLOYEE: "PATIENTS SPOUSE DOES NOT BELIEVE WHEN OXYGEN IS CONNECTED TO THE BACK THAT IT IS DELIVERING THAT OXYGEN EFFECTIVELY. PATIENT DESATS WHEN USING CONCENTRATOR BUT SATS ARE GOOD WHEN USING OXYGEN FROM THE VENT.". ADDITIONAL INFORMATION IN THE FORM OF AN EMAIL BETWEEN THE PATIENT'S WIFE AND THE REACT HEALTH EMPLOYEE WAS LATER PROVIDED TO THE VENTEC COMPLAINT HANDLING UNIT: "YOU AND I HAD A TEAMS CALL ON (B)(6) 2024 AT 4 PM EST. YOU SAW THERE WAS NO O2 ALARM SETTING ON THE BLEED IN OXYGEN FUNCTION ON THE VENTILATOR SUPPLIED TO MY HUSBAND BY ADAPT HEALTH. YOU HAD ONE OF THE VENTILATORS SENT TO YOUR COMPANY REACT HEALTH, TO TROUBLESHOOT. I HAVE OUR ATTORNEY [REDACTED] COPIED THIS CORRESPONDENCE. I WILL BE PUTTING TOGETHER A TIMELINE OF WHAT WE HAVE GONE THROUGH AND DELIVERING IT TO HIS LAW FIRM. MY HUSBAND SPENT 5 DAYS IN THE ICU BEGINNING JULY 5 IN THE EMERGENCY DEPT DUE TO MUCUS PLUGS CAUSED DUE TO INABILITY FOR HIM TO USE A HUMIDIFIER CHAMBER WITH THE VENTILATOR DUE TO NO EXTERNAL OXYGEN ABILITIES OF THE VENTILATORS YOU PROVIDED [REDACTED]. VOCSN - EXTERNAL OXYGEN WARNING SENSOR - CHECK O2 SOURCE, CHECK O2 CONNECTION IS A NECESSITY WHEN ON EXTERNAL OXYGEN. NO ALARMS ON THESE VENTS; - PATIENT CONTINUALLY DESATURATED ON EXTERNAL OXYGEN. WHEN PUT ON 2 LITERS INTERNAL OXYGEN READINGS IMMEDIATELY WENT UP TO 99 & 100; - MUTIPLE [SIC] CONCENTRATORS WERE TESTED WITH EXTERNAL OXYGEN BLEED IN FUNCTION SELECTED; - OXYGEN TANK HOOK UP ALSO DID NOT RELIEVE DESATURATION ; - INTERNAL CONCENTRATORS ONLY HAVE ABOUT 1 MONTH BEFORE NEEDING SERVICE IF ON 24-7 USAGE; - [REDACTED] FROM [REDACTED] WAS HERE AND PERFORMED TESTS AND WITNESSED; - NEW CONCENTRATOR WORKS; - IF ON BLEED IN SETTING AND NO OXYGEN IS INTRODUCED THERE IS NO ALARM; - IT IS NOT READING EXTERNAL OXYGEN AT ALL. - NO DETECTION OF LACK OF FLOW; - THE OLDER SOFTWARE HAD THIS FUNCTIONALITY. COUGH ASSIST, NEBULIZING, SUCTION , HUMIDIFIER ARE NOT FUNCTIONAL IF THE PATIENT NEEDS OXYGEN AS THEY CANNOT RECEIVE INTERNAL OXYGEN WHILE THESE PROGRAMS ARE RUN ON THE VOCSN SYSTEM. MY HUSBAND IS DEPENDENT ON ALL THESE FUNCTIONS. HE HAS USED THE VOCSN SINCE 2020. WE ARE COMPLETELY AWARE THESE FUNCTIONS WORKED ON VENTILATORS USED BEFORE THE ONES PROVIDED IN (B)(6). YOU ARE FULLY AWARE OF THIS ISSUE, AND I HIGHLY SUGGEST YOU ESCALATE THIS PROBLEM TO YOUR TECHNICAL TEAM IMMEDIATELY.". NO FURTHER DETAILS WERE PROVIDED TO VENTEC. THE PATIENT SURVIVED THE REPORTED EVENT, BUT REQUIRED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370272 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+O+C+S+N, ENGLISH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization