BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 11536673 · Received March 20, 2021

    Report

    Report Number
    3013095415-2021-00008
    Event Type
    Death
    Date Received
    March 20, 2021
    Date of Event
    September 28, 2020
    Report Date
    March 19, 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

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO VENTEC FOR AN EVALUATION. VENTEC CONFIRMED THE DEVICE WAS OPERATING TO SPECIFICATION DURING THE EVENT. THE DEVICE'S ELECTRONIC LOGS WERE DOWNLOADED FOR FURTHER EVALUATION. OTHER UNRELATED REPAIRS WERE MADE TO THE DEVICE AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. VENTEC REVIEWED THE ELECTRONIC LOGS AROUND THE REPORTED EVENT DATE AND TIME, WHICH INDICATED NOMINAL DEVICE OPERATION FOR THE THERAPIES BEING UTILIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VENTEC, THAT THE "VOCSN WAS ALARMING, RT WENT TO THE ROOM, STATES PATIENT WAS NON-RESPONSIVE / DECEASED. (B)(6) DIRECTOR OF RESPIRATOR FELT IT WAS NOT VENTILATOR RELATED." DELTA REPORTED THAT THE PATIENT HAD MANY HEALTH CONDITIONS THAT CAUSED/CONTRIBUTED TO THE PATIENT'S DEATH. THERE WAS NO ALLEGATION OF A PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429976 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Death