BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENGSTROM

    MDR report key: 11921000 · Received June 2, 2021

    Report

    Report Number
    2112667-2021-01403
    Event Type
    Death
    Date Received
    June 2, 2021
    Date of Event
    May 9, 2021
    Report Date
    November 4, 2021
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K041775
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. REVIEW OF THE LOGS INDICATED THE PATIENT WAS PLACED ONTO THE VENTILATOR ON (B)(6) -2021 AND THAT SYSTEM CHECKOUT WAS NOT PERFORMED BEFORE USE AS RECOMMENDED BY THE USER MANUAL. ON (B)(6) 2021 AT 6:32 AM, THE VENT STARTED ALARMING ON AND OFF WITH THE NO EXHALATION FLOW SENSOR AND APNEA ALARMS, BOTH OF WHICH CONTINUED FOR OVER 16 MINUTES. THE LOGS INDICATE THAT THERAPY WAS BEING PROVIDED UNINTERRUPTED AT THE SETTINGS THAT THE CLINICIAN HAD CHOSEN, AND THAT USERS SILENCED THE ALARM EIGHT TIMES. ACCORDING TO THE CUSTOMER, A NURSE NOTICED THAT THE PATIENT'S SATURATION WAS LOW AND ENTERED THE ROOM AT 6:39 AM TO ATTEND TO HIM, CHANGING THE VENTILATION MODE TO PRESSURE-CONTROLLED VENTILATION (PCV) AT 6:41 AM. THE USER MOVED THE DEVICE IN AND OUT OF STANDBY AND MONITORING ONLY MODES UNTIL FINALLY POWERING OFF THE SYSTEM AND REBOOTING THE DEVICE AT 6:47 AM. THE VENTILATOR WAS PLACED BACK INTO THERAPY MODE IMMEDIATELY AFTER REBOOT, BUT THE NO EXPIRATORY FLOW SENSOR AND APNEA ALARMS CONTINUED. LESS THAN A MINUTE LATER, THE VENTILATOR WAS PLACED INTO STANDBY MODE, THE AIR AND OXYGEN SUPPLY DISCONNECTED, AND THE POWER CORD UNPLUGGED. CHECKOUT WAS INITIATED WITHOUT GAS SUPPLIES CONNECTED, WHICH CAUSED THE SYSTEM CHECKOUT TO FAIL. THE DEVICE WAS POWERED OFF AGAIN AT 7:18 AM AND NOT POWERED BACK ON UNTIL THE FOLLOWING DAY. PER THE CUSTOMER SURVEY, THE PATIENT PASSED AWAY AT 9:17 AM ON (B)(6) 2021.

    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.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED FINDING A PATIENT WITH LOW SATURATION. THE UNIT WAS DISCONNECTED SO THAT IT COULD BE SERVICED AND REPLACED WITH ANOTHER UNIT. THE PATIENT WENT INTO CARDIAC ARREST, RESUSCITATION MANEUVERS WERE PERFORMED WITHOUT SUCCESS. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818071 ENGSTROM CRITICAL CARE VENTILATER CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death