BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 14312174 · Received May 6, 2022

    Report

    Report Number
    3013095415-2022-00534
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    April 10, 2022
    Report Date
    April 10, 2022
    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

    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

    CORRECTED INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 002 - SECTION H10, ADDITIONAL MANUFACTURE NARRATIVE OF SUPPLEMENTAL MEDWATCH REPORT 001 STATED: H6: THE DEVICE WAS EVALUATED BY VENTEC WHERE THE REPORTED ISSUE OF THE DEVICE PROVIDING LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS WAS CONFIRMED. DURING EVALUATION, VENTEC ALSO OBSERVED THAT THE VENTILATOR WAS UNABLE TO MAINTAIN PEEP (POSITIVE END EXPIRATORY PRESSURE) AND ITS EXHALED TIDAL VOLUME (VTE) LEVELS WERE LOW. VENTEC REPLACED THE INTERNAL FLOW TRANSDUCER (IFT) TO RESOLVE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE REPORTED ISSUE WAS THE IFT. SECTION H10, ADDITIONAL MANUFACTURE NARRATIVE OF SUPPLEMENTAL MEDWATCH REPORT 001 SHOULD HAVE STATED: H6: THE DEVICE WAS EVALUATED BY VENTEC WHERE THE REPORTED ISSUE OF THE DEVICE PROVIDING LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS COULD NOT BE DUPLICATED DURING TESTING. VENTEC DID OBSERVE, HOWEVER, THAT THE FIO2 LEVELS WERE UNSTABLE AND AT THE TIME OF TESTING WERE ACTUALLY DELIVERING HIGHER THAN SET. IN ADDITION, VENTEC OBSERVED THAT THE VENTILATOR WAS UNABLE TO MAINTAIN PEEP (POSITIVE END EXPIRATORY PRESSURE) AND THAT ITS EXHALED TIDAL VOLUME (VTE) LEVELS WERE UNSTABLE, OFTEN GOING LOWER OR HIGHER THAN EXPECTED (OR SET). THESE FLUCTUATIONS WERE ATTRIBUTED TO THE DEVICE'S INTERNAL FLOW TRANSDUCER (IFT). VENTEC REPLACED THE IFT TO RESOLVE THE OBSERVED ISSUES. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. DESPITE VENTEC BEING UNABLE TO DUPLICATE THE REPORTED LOW FIO2 ISSUE DURING TESTING, IT'S REASONABLE TO CONCLUDE THAT THE OBSERVED FAILURE OF THE IFT WHICH CAUSED THE OBSERVED UNSTABLE VTE (LOW), PEEP AND FIO2 LEVELS (HIGH), DURING TESTING LIKELY ALSO HAD AN IMPACT ON THE FIO2 DELIVERY DURING THE REPORTED EVENT. THEREFORE, BASED ON THE INFORMATION AVAILABLE THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE BOTH THE REPORTED AND OBSERVED ISSUES WAS THE IFT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY VENTEC WHERE THE REPORTED ISSUE OF THE DEVICE PROVIDING LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS WAS CONFIRMED. DURING EVALUATION, VENTEC ALSO OBSERVED THAT THE VENTILATOR WAS UNABLE TO MAINTAIN PEEP (POSITIVE END EXPIRATORY PRESSURE) AND ITS EXHALED TIDAL VOLUME (VTE) LEVELS WERE LOW. VENTEC REPLACED THE INTERNAL FLOW TRANSDUCER (IFT) TO RESOLVE BOTH THE REPORTED AND OBSERVED ISSUES. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE REPORTED AND OBSERVED ISSUES WAS THE IFT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS DELIVERING LOWER FIO2 (FRACTION OF INSPIRED OXYGEN) THAN SET ON THE FIO2 CONTROL. THE PATIENT, A (B)(6) FEMALE, WAS BEING TRANSPORTED BY EMS FOR AN UNRELATED MEDICAL ISSUE TO AN AREA HOSPITAL. THE PATIENT WAS INTUBATED BY MEDICAL PERSONNEL AND PLACED ON THE VOCSN FOR TRANSPORT. DURING TRANSPORT, PERSONNEL WERE UNABLE TO GET THE VOCSN TO INCREASE THE FIO2 BEING DELIVERED TO THE PATIENT. AS A RESULT, THE PATIENT DESATURATED AND MEDICAL PERSONNEL HAD TO INTERVENE BY REMOVING THE PATIENT FROM THE VOCSN AND MANUALLY VENTILATING HER FOR THE DURATION OF THE TRANSPORT (APPROXIMATELY 40 MINUTES). AFTER MANUALLY VENTILATING THE PATIENT, HER O2 SATURATION LEVELS WERE ABLE TO INCREASE INTO THE 90S. THE PATIENT OUTCOME WAS NOT REPORTED. NO FURTHER DETAILS ABOUT THE PATIENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281327 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-01184-000

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention