BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 8311682 · Received February 6, 2019

    Report

    Report Number
    3013095415-2019-00001
    Event Type
    Death
    Date Received
    February 6, 2019
    Date of Event
    December 10, 2018
    Report Date
    December 28, 2018
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007006
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER ON 12/13/2018. THE EVENT LOGS WERE DOWNLOADED FROM THE DEVICE AND REVIEWED. EVENT LOGS FROM THE DEVICE CORRELATE TO THE EVENT DESCRIPTIONS DESCRIBED BY THE FACILITY AND DO NOT INDICATE ANY DEVICE MALFUNCTION. THE DEVICE PASSED ALL TESTING DURING THE INVESTIGATION AND WAS FOUND TO OPERATE AND ALARM AS SPECIFIED. THE DEVICE SCREEN WAS NOT LOCKED WHEN THE USER CLEANED THE SCREEN, AND THE EVENT LOGS SHOW FIVE TOUCHSCREEN TOUCHES WITHIN THREE SECONDS TO ACCESS THE PRE-USE SCREEN WHICH PAUSES VENTILATION. EACH SCREEN TOUCH RESULTS IN A CHANGE TO THE IMAGE DISPLAYED ON THE DEVICE SCREEN. PER THE CLINICAL MANUAL, THE USER IS TO "PAY CLOSE ATTENTION TO THE LCD SCREEN WHILE CLEANING, TO ENSURE BUTTONS ON THE TOUCHSCREEN ARE NOT UNINTENTIONALLY PRESSED." ADDITIONALLY THE DEVICE PROVIDES A TOUCHSCREEN LOCK THAT CAN BE UTILIZED WHEN CLEANING THE TOUCHSCREEN TO PREVENT UNINTENTIONAL OPERATION. EACH PRE-USE TEST SCREEN DISPLAYS THE MESSAGE "VENTILATION IS PAUSED". IT IS DETERMINED THAT UNINTENTIONAL USE ERROR LEAD TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON 12/11/2018 THAT A PATIENT EXPIRED WHILE USING A VENTILATOR. THE DEVICE WAS FOUND ON ONE OF THE PRE-USE TEST SCREENS. THE EVENT DATE WAS (B)(6) 2018 AT APPROXIMATELY 7PM EST. PHONE CALL WITH THE FACILITY ON (B)(6) 2018 PROVIDED THE ADDITIONAL INFORMATION AND TIMELINE: RT CHECKED PATIENT CO2 AROUND 6:36PM. THE PT WAS TAKEN OFF THE VENTILATOR MOMENTARILY FOR THIS CHECK, AND THEN PLACED BACK ON THE VENTILATOR. THE VENTILATOR WAS REPORTED TO BE VENTILATING NORMALLY. SOMETIME BETWEEN 6:36P-7PM AN RT REPORTEDLY WIPED DOWN THE SCREEN OF THE VENTILATOR WITH AN ANTIBACTERIAL WIPE. AT 7PM AN AID ENTERED THE ROOM AND FOUND THE PT DECEASED. THE VENTILATOR WAS REPORTED TO BE ON A SCREEN OF THE PRE-USE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103081 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001 00855573007006

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death