BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 17927840 · Received October 12, 2023

    Report

    Report Number
    3013095415-2023-00627
    Event Type
    Death
    Date Received
    October 12, 2023
    Date of Event
    September 17, 2023
    Report Date
    September 19, 2023
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTED INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001 ¿ SECTION D4, MODEL #, OF THE INITIAL MEDWATCH REPORT STATED: PRT-01184-000. SECTION D4, MODEL #, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: V+C+S+N+PRO, ENGLISH. SECTION D4, UDI #, OF THE INITIAL MEDWATCH REPORT STATED: (B)(4). SECTION D4, UDI #, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(4).

    Additional Manufacturer Narrative · 0

    H6: THE DEVICE WAS EVALUATED BY VENTEC WHERE THE REPORTED ISSUE OF THE VENTILATOR BEING UNABLE TO MAINTAIN FIO2 LEVELS WAS CONFIRMED. VENTEC ALSO OBSERVED THAT THE DEVICE WAS UNABLE TO MAINTAIN PEEP (POSITIVE END EXPIRATORY PRESSURE). VENTEC REPLACED THE INTERNAL FLOW TRANSDUCER (IFT) TO RESOLVE THE REPORTED ISSUES. PROPER DEVICE OPERATION WAS THEN CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THAT THE CAUSE OF THE REPORTED ISSUES WAS THE IFT.

    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

    IT WAS REPORTED TO VENTEC THAT THE VENTILATOR WAS UNABLE TO MAINTAIN FIO2 (FRACTION OF INSPIRED OXYGEN) LEVELS, RESULTING IN PATIENT DESATURATION. THE FACILITY WAS CONTACTED AND THEY PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: "THIS FAILURE WAS ASSOCIATED TO ONE PATIENT. WHEN THE VOCSN IS USING A HIGH-PRESSURE OXYGEN SOURCE, THERE IS AN AUDIBLE "CLICKING" SOUND THAT I ASSUME IS A VALVE OF SOME KIND. AT THREE SEPARATE TIMES DURING MY TRANSPORT OF THE PATIENT, THAT "CLICKING SOUND" WOULD STOP AND THE PATIENT'S PULSE OXIMETRY LEVELS WOULD DROP. I NOTED DURING THAT TIME, THE AMOUNT OF OXYGEN IN THE TANK WAS NOT CHANGING, INDICATING THE IT WAS NO LONGER PULLING OXYGEN FROM THE TANK. OXYGEN TANKS WERE SWITCHED AND ALL HOSE CONNECTIONS WERE ENSURED TO BE TIGHT, HOWEVER THE PROBLEM REMAINED. I SHUT OFF AND TURNED ON THE HP OXYGEN IN AN ATTEMPT TO GET IT TO WORK, HOWEVER THAT WAS UNSUCCESSFUL. I HAD TO REMOVE THE PATIENT FROM NON-INVASIVE VENTILATION AND PROVIDE OXYGEN WITH STANDARD OXYGEN MASK. THE ONLY WAY THAT THE ISSUE RESOLVED WAS TO SHUT OFF THE VOCSN, TURN IT BACK ON, AND PERFORM THE PRE-USE TEST AGAIN. THEN THE VENTILATOR WOULD START USING OXYGEN AGAIN." THE REPORTER FURTHER ADVISED THAT THE PATIENT, A 91 YEAR-OLD MALE, DID NOT SURVIVE THE REPORTED EVENT. THE REPORTER, A PARAMEDIC (CCP, FP-C), PROVIDED THE FOLLOWING STATEMENT TO VENTEC: "I DO NOT BELIEVE THIS EVENT CAUSED THE OUTCOME. THE PATIENT WAS EXPERIENCING SIGNIFICANT BREATHING PROBLEMS CAUSED BY POSSIBLE ASPIRATION PRIOR TO THE VENTILATOR USE. ULTIMATELY, THE PATIENT HAD A VALID ADVANCED DIRECTIVE (DO NOT RESUSCITATE, DO NOT INTUBATE ORDER) AND THE FAMILY DID NOT WANT AGGRESSIVE LIFE-SAVING CARE. THE AMOUNT OF TIME THE PATIENT WAS NOT RECEIVING OXYGEN WAS VERY MINIMAL COMPARED TO TOTAL AMOUNT OF TIME OF TRANSPORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683652 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+C+S+N+PRO, ENGLISH

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male Death