BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 22376146 · Received July 1, 2025

    Report

    Report Number
    3013095415-2025-00586
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 7, 2025
    Report Date
    July 1, 2025
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007747
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE INITIAL REPORTER TO SEE IF THE DEVICE WOULD BE RETURNED TO VENTEC FOR AN EVALUATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. IN THE EVENT THAT THE DEVICE IS RECEIVED OR ADDITIONAL INFORMATION IS PROVIDED, VENTEC WILL SUBMIT A FOLLOW-UP REPORT AS DEFINED BY 21 CFR 803.56. VENTEC PERFORMED A REVIEW OF THE DEVICE'S MANUFACTURING RECORDS WHICH SHOWED ALL REQUIREMENTS WERE MET. FINAL TEST SPECIFICATIONS WERE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. TREND ANALYSIS AND RISK ANALYSIS WERE CONSIDERED ACCEPTABLE. THE DEVICE WAS NOT RETURNED TO VENTEC FOR AN EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO A REACT HEALTH (VENTEC) VENTILATION PRODUCT SUPPORT SPECIALIST THAT A PATIENT DESATURATED WHILE ON THE DEVICE. THE INITIAL REPORTER, A RESPIRATORY THERAPIST (RT), ADVISED THAT THE PATIENT WAS BEING SET UP AND THAT THEIR OXYGEN SATURATION WAS 92% 2LPM NC. ONCE ON THE VENTILATOR, THEIR OXYGEN SATURATION DROPPED INTO THE LOW TO MID 70S. THE RT ADVISED THAT THE PATIENT'S OXYGEN SATURATION DID NOT IMPROVE SIGNIFICANTLY AFTER INCREASING THE FLOW TO 5LPM. THE VENTILATION PRODUCT SUPPORT SPECIALIST THEN WALKED THE RT THROUGH ASSESSING THAT THE CONNECTIONS WERE FULLY SEATED AND THEY REVIEWED THE PATIENT'S SETTINGS, ALL OF WHICH SEEMED APPROPRIATE. THE PATIENT SURVIVED THE EVENT. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE, HOWEVER, THE PATIENT DID ALLEGEDLY DESATURATE DURING THE EVENT NECESSITATING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. ADDITIONALLY, THERE WERE NO REPORTS OF A DEVICE OR USAGE ISSUE WHICH MAY HAVE CONTRIBUTED THE PATIENT'S ALLEGED DESATURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430342 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+O+C+S+N, ENGLISH 00855573007747

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention