BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 12776054 · Received November 8, 2021

    Report

    Report Number
    3013095415-2021-00664
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    October 18, 2021
    Report Date
    October 18, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6: VENTEC EVALUATED THE DEVICE BUT WAS INITIALLY UNABLE TO DUPLICATE OR CONFIRM ANY CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S REPORTED DISCOMFORT. THE ELECTRONIC RECORDS WERE THEN DOWNLOADED FOR ANALYSIS, HOWEVER, THE DEVICE'S DAY AND TIME WAS NEVER SET. AS A RESULT, VENTEC WAS UNABLE TO FIND THE ELECTRONIC DATA SPECIFIC TO THE REPORTED EVENT WHICH WOULD HAVE INCLUDED THE DEVICES SETTINGS DURING THE EVENT. ADDITIONAL TESTING WAS THEN PERFORMED ON THE DEVICE WHERE VENTEC OBSERVED THAT ITS INTERNAL FLOW TRANSDUCER (IFT) WAS NOT PERFORMING AS EXPECTED. VENTEC REPLACED THE IFT TO RESOLVE THE OBSERVED ISSUE. PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. BASED ON THE INFORMATION AVAILABLE, IT'S REASONABLE TO CONCLUDE THAT THE LIKELY CAUSE OF THE REPORTED PATIENT DISCOMFORT WAS THE IFT NOT PERFORMING AS EXPECTED. FURTHER TESTING OF THE REMOVED IFT INDICATED THAT THE ROOT CAUSE OF THE OBSERVED IFT PERFORMANCE ISSUES WAS SOLENOID VALVE 5 (SV5) LOCATED ON THE FLOW BOARD OF THE IFT.

    Additional Manufacturer Narrative · 0

    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 WHEN SWITCHING FROM COUGH THERAPY TO VENTILATION, THE DEVICE BEGAN TO AUTO-TRIGGER WHICH CAUSED THE PATIENT DISTRESS. THE DEVICE SETTINGS WERE ADJUSTED AND THE PATIENT CIRCUIT WAS CHANGED, BUT THAT DID NOT RESOLVE THE REPORTED ISSUE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670168 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention