BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 19852041 · Received July 29, 2024

    Report

    Report Number
    3013095415-2024-00556
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    June 27, 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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE DEVICE WAS EVALUATED BY VENTEC WHERE THE REPORTED ISSUE OF AN UNEXPECTED LOSS OF POWER WAS CONFIRMED. VENTEC OPENED THE DEVICE TO PERFORM AN INTERNAL INSPECTION AND OBSERVED THAT THE DEVICE'S COUGH ASSIST VALVE HAD A TORN POPPET RING. VENTEC REPLACED THE COUGH ASSIST VALVE TO RESOLVE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS THEN CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE REPORTED ISSUE WAS THE COUGH ASSIST VALVE'S POPPET RING WAS TORN.

    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 EVENT WAS REPORTED TO VENTEC VIA EMAIL: "I AM IN NEED OF RA AND SHIPPING INFORMATION TO SEND IN A VOCSN THAT I HAVE NEEDING REPAIRS, THE PATIENT ENDED UP IN THE HOSPITAL WEEKEND DUE TO HIS VOCSN ALARMING AND SHUTTING OFF ON IT'S OWN, MY RT HAS ALREADY PERFORMED A TROUBLESHOOT AND UNIT NEEDS REPAIRS." VENTEC REACHED OUT TO THE REPORTER IN ORDER TO OBTAIN ADDITIONAL INFORMATION AND WAS PROVIDED WITH THE FOLLOWING: "VENT SUDDENLY GLITCHED/SHUT OFF WHILE PLUGGED IN. PT'S FAMILY/CAREGIVERS WERE UNABLE TO RESET OR TROUBLESHOOT VENT, THUS LEADING TO PT REQUIRING MANUAL VENTILATION VIA AMBUBAG UNTIL EMS ARRIVED AND TRANSPORTED PT TO HOSPITAL." THE PATIENT SURVIVED THE REPORTED EVENT AND THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. HOWEVER, MEDICAL INTERVENTION WAS REQUIRED IN ORDER TO PREVENT PERMANENT IMPAIRMENT/DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994248 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+O+C+S+N, ENGLISH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| H