BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENGSTROM

    MDR report key: 11917066 · Received June 1, 2021

    Report

    Report Number
    2112667-2021-01390
    Event Type
    Death
    Date Received
    June 1, 2021
    Date of Event
    April 30, 2021
    Report Date
    December 17, 2021
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K041775
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. BASED ON THE COMPLAINT INFORMATION AND THE LOGS, THE DEVICE PERFORMED AS DESIGNED, INCLUDING ALARMING APPROPRIATELY. THERE IS NO EVIDENCE OF A MALFUNCTION OR FAILURE OF THE ENGSTRAM VENTILATOR. IT IS UNCLEAR FROM THE EVIDENCE HOW THE PATIENT BECAME DISCONNECTED FROM THE VENTILATOR. ONE POSSIBILITY FOR THE PATIENT DISCONNECT ERROR WOULD BE A FAULT IN THE EXPIRATORY FLOW SENSOR HOUSED WITHIN THE EXHALATION VALVE ASSEMBLY. GE WAS UNABLE TO EXAMINE THE SENSOR, AS THE CUSTOMER HAD DISPOSED OF IT. HOWEVER, A POST-EVENT CHECKOUT BY THE FE INDICATED THAT THE DEVICE WAS WORKING PROPERLY. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE CANNOT BE DETERMINED.

    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. NO REPORT OF PATIENT INVOLVEMENT. 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.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE PATIENT WAS VENTILATED IN NON-INVASIVE VENTILATION MODE. WHEN THE PATIENT CONDITION REPORTEDLY DETERIORATED, CHANGE TO VOLUME CONTROL MODE WAS ATTEMPTED, BUT THE UNIT DID NOT CYCLE. THE PATIENT WAS VENTILATED MANUALLY. 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
    807986 ENGSTROM CRITICAL CARE VENTILATER CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death