BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 12686892 · Received October 24, 2021

    Report

    Report Number
    3013095415-2021-00623
    Event Type
    Death
    Date Received
    October 24, 2021
    Date of Event
    September 22, 2021
    Report Date
    September 28, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6, MEDICAL DEVICE PROBLEM CODE, OF THE INITIAL MEDWATCH REPORT INDICATED: 3189 SECTION H6, MEDICAL DEVICE PROBLEM CODE, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE INDICATED: 3005 & 2900. SECTION H6, INVESTIGATION FINDINGS CODE, OF THE INITIAL MEDWATCH REPORT INDICATED: 213 SECTION H6, INVESTIGATION FINDINGS CODE, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE INDICATED: 3233. SECTION H6, INVESTIGATION CONCLUSIONS CODE, OF THE INITIAL MEDWATCH REPORT INDICATED: 67 SECTION H6, INVESTIGATION CONCLUSIONS CODE, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE INDICATED: 11. SECTION H10: ADDITIONAL MANUFACTURER NARRATIVE, OF THE INITIAL MEDWATCH REPORT INDICATED: H6: VENTEC DOWNLOADED THE ELECTRONIC RECORDS FROM THE DEVICE FOR REVIEW. VENTEC ANALYZED THE DEVICE LOGS AND FOUND NO INDICATION OF INOPERATIVE (INOP) CONDITIONS, OR ANY UNEXPECTED POWER OFF EVENTS. THE DEVICE WAS THEN EVALUATED AND PROPER OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. BASED ON THE INFORMATION AVAILABLE, IT'S REASONABLE TO CONCLUDE THAT NO DEVICE MALFUNCTION OCCURRED DURING THE REPORTED EVENT. SECTION H10: ADDITIONAL MANUFACTURER NARRATIVE, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE INDICATED: H6: VENTEC DOWNLOADED THE ELECTRONIC RECORDS FROM THE DEVICE FOR REVIEW. VENTEC ANALYZED THE DEVICE LOGS AND FOUND NO INDICATION OF INOPERATIVE (INOP) CONDITIONS, OR ANY UNEXPECTED POWER OFF EVENTS. VENTEC DID CONFIRM THAT THE DEVICE HAD ALARMED DURING THE REPORTED EVENT DUE TO LOW INSPIRATORY PRESSURE AND PATIENT CIRCUIT DISCONNECT. VENTEC PERFORMED AN INITIAL EVALUATION OF THE DEVICE BUT WAS NOT ABLE TO DUPLICATE THE REPORTED ISSUES. AT THIS TIME, IT'S UNKNOWN WHETHER THE ALARMS WERE DUE TO CLINICAL USE OR DUE TO A POTENTIAL DEVICE MALFUNCTION. VENTEC CONTINUES TO INVESTIGATE THE REPORTED ISSUE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56. NEW INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001: H6: DURING SUBSEQUENT TESTING OF THE DEVICE, VENTEC WAS ABLE TO DUPLICATE THE REPORTED ALARM FOR LOW INSPIRATORY PRESSURE AND ALSO OBSERVED THAT THE DEVICE'S EXHALED TIDAL VOLUME (VTE) LEVELS WERE LOW. VENTEC REPLACED THE INTERNAL FLOW TRANSDUCER (IFT) TO RESOLVE THE REPORTED ISSUE OF LOW VTE. VENTEC REPLACED THE EXHALATION CONTROL MODULE (ECM) TO RESOLVE THE REPORTED ISSUE OF LOW INSPIRATORY PRESSURE. THE CAUSE OF THE REPORTED PATIENT CIRCUIT DISCONNECT ALARMS COULD NOT BE CONCLUSIVELY DETERMINED. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. BASED ON THE INFORMATION AVAILABLE, VENTEC WAS UNABLE TO DETERMINE IF THE DEVICE USE CONTRIBUTED TO THE PATIENT OUTCOME.

    Additional Manufacturer Narrative · 1

    VENTEC DOWNLOADED THE ELECTRONIC RECORDS FROM THE DEVICE FOR REVIEW. VENTEC ANALYZED THE DEVICE LOGS AND FOUND NO INDICATION OF INOPERATIVE (INOP) CONDITIONS, OR ANY UNEXPECTED POWER OFF EVENTS. THE DEVICE WAS THEN EVALUATED AND PROPER OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. BASED ON THE INFORMATION AVAILABLE, IT'S REASONABLE TO CONCLUDE THAT NO DEVICE MALFUNCTION OCCURRED DURING THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS ON A PATIENT AT THE TIME OF DEATH. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION; HOWEVER, THE REPORTER ADVISED THAT THEY WERE UNSURE WHETHER OR NOT THE DEVICE USE WAS A CONTRIBUTING FACTOR. THE REPORTER HAS REQUESTED THAT VENTEC PERFORM AN EVALUATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584947 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Death