BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 12595475 · Received October 7, 2021

    Report

    Report Number
    3013095415-2021-00538
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    September 9, 2021
    Report Date
    September 9, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO VENTEC FOR AN EVALUATION. THE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VENTEC THAT A PATIENT WAS ON THE VOCSN AND WAS BEING MANAGED FOR ORGAN HARVEST. THE HOSPITAL EXPERIENCED DIFFICULTY MANAGING THE PATIENT ON THE VENTILATOR AND HAD TO BAG THE PATIENT TO RESOLVE THE ISSUE. ONCE THE ISSUE WAS RESOLVED, THE PATIENT WOULD BE PLACED BACK ON THE VOCSN AND IN 20 MINUTES THE PATIENT WOULD BEGINE TO DECOMPENSATE AGAIN. THE PATIENT WAS THEN PLACED ON ANOTHER VENTILATOR WITH NO OTHER ISSUES. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. ADDITIONALLY, THE INITIAL REPORTER DID NOT PROVIDE THE DEVICE'S SERIAL NUMBER. AS A RESULT, (MODEL NUMBER, CATALOG NUMBER, SERIAL NUMBER AND UDI NUMBER) ARE "UNKNOWN", AND (DEVICE MANUFACTURING DATE) SHALL BE LEFT BLANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485450 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention