BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENGSTROM

    MDR report key: 8095660 · Received November 21, 2018

    Report

    Report Number
    2112667-2018-02311
    Event Type
    Death
    Date Received
    November 21, 2018
    Date of Event
    October 17, 2018
    Report Date
    January 17, 2019
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K041775
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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. PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE PRODUCT ENGINEERING COMPLETED AN INVESTIGATION OF THIS EVENT. PER THE DEVICE LOGS, THE USER CONTINUED TO USE THE VENTILATOR DESPITE THE SYSTEM CHECKOUT FAILING PARTS OF THE CHECKOUT, WHICH CAUSED THE MACHINE TO CONTINUALLY ALARM WITH PATIENT CONNECTION LEAK, APNEA, AND LOW MINUTE VOLUME ALARMS. TESTING OF THE UNIT BY GE HEALTHCARE SERVICE PERSONNEL COULD NOT DUPLICATE THE REPORTED ISSUE AND THERE IS NO INDICATION OF MACHINE FAILURE. PER THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED ISSUE IS UNDETERMINED. THE REPORTED ISSUE WAS LIKELY DUE TO AN UNIDENTIFIED LEAK THAT WAS FOUND DURING CHECKOUT BY THE USER.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, WHILE VENTILATING A (B)(6) NEONATAL PATIENT, THE SYSTEM WAS SUSPECTED TO HAVE MALFUNCTIONED AND THE PATIENT DIED. PRELIMINARY TESTING BY GE HEALTHCARE FIELD ENGINEER FOUND THE DEVICE PASSED TESTING WITH NO FAULTS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934616 ENGSTROM CRITICAL CARE VENTILATER CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 189 DA Death