BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANCE

    MDR report key: 22013318 · Received May 13, 2025

    Report

    Report Number
    2112667-2025-04011
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 15, 2025
    Report Date
    October 24, 2025
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    UDI-DI
    00840682102322
    PMA / PMN Number
    K172045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE (GEHC) INVESTIGATION HAS BEEN COMPLETED, AND THE ROOT CAUSE WAS IDENTIFIED AS USE ERROR. BASED ON REVIEW OF THE DEVICE LOGS IT WAS CONFIRMED THAT THERE WAS NO DEVICE MALFUNCTION. IT WAS DETERMINED THAT THE CLINICIAN DID NOT PUSH THE START CASE BUTTON AND THUS DID NOT PLACE THE AVANCE CS2 MACHINE INTO THERAPY AND START FRESH GAS FLOW. NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE. THESE INVESTIGATION FINDINGS HAVE BEEN PROVIDED TO THE END USER BY GE HEALTHCARE.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A5 AND BLOCK A6: NO INFORMATION AVAILABLE. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT WAS CONNECTED TO AN AVANCE CS2 WHEN THE UNIT ALARMED FOR NO FRESH GAS FLOW. IT WAS ALLEGED THE USER WAS UNABLE TO PROVIDE GAS FLOW TO THE PATIENT AND THE PATIENT DESATURATED. THE USER SWITCHED THE UNIT FROM BAG TO VENT MODE AND RETURNED TO BAG MODE. THE USER WAS THEN ABLE TO RESUME GAS FLOW TO THE PATIENT, THE PATIENT STABILIZED, AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT SEQUELAE. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368242 AVANCE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. CS2 NA 00840682102322

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other