BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENGSTROM CS

    MDR report key: 8094230 · Received November 21, 2018

    Report

    Report Number
    2112667-2018-02302
    Event Type
    Death
    Date Received
    November 21, 2018
    Date of Event
    October 24, 2018
    Report Date
    March 14, 2019
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K041775
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM BUT DID NOT CONFIRM THE REPORTED ISSUE. GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. ENGINEERING REVIEW OF THE DEVICE LOGS SHOW THAT THE CASE WAS STARTED ON 10-OCT-2018. PRIOR TO THE START OF THE CASE, SEVERAL CHECKOUT STEPS WERE FAILED INCLUDING THE NEONATAL FLOW SENSOR (NFS) ZERO. THROUGHOUT THE CASE THE ENGSTROM ALARMED TO ALERT THE USER THAT THE FLOW SENSING WAS INACCURATE. ON 12-OCT-2018, THE ENGSTROM BEGAN ALARMING FOR HIGH AIRWAY PRESSURE. BECAUSE OF THE FAILED NFS ZERO, THE ENGSTROM WAS UNDER-READING THE DELIVERED TIDAL VOLUME AND SUBSEQUENTLY INCREASING DELIVERED VOLUME. THE RESULT WAS HIGHER TIDAL VOLUMES AND THEREFORE INCREASED PRESSURE DURING EACH BREATH. THE ROOT CAUSE OF THE ALLEGED EXCESSIVE TIDAL VOLUME WAS THE USER IGNORING THE FAILURE OF THE NEONATAL FLOW SENSOR (NFS) ZERO CHECKOUT STEP.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, WHILE VENTILATING A PEDIATRIC PATIENT, DELIVERED TIDAL VOLUME WAS HIGHER THAN EXPECTED. IT WAS FURTHER REPORTED THAT, AT SOME POINT LATER, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936558 ENGSTROM CS CRITICAL CARE VENTILATER CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death