BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANCE CS2

    MDR report key: 14305696 · Received May 6, 2022

    Report

    Report Number
    2112667-2022-01139
    Event Type
    Death
    Date Received
    May 6, 2022
    Date of Event
    April 4, 2022
    Report Date
    September 2, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. ETHNICITY AND RACE NOT AVAILABLE. UNIQUE IDENTIFIER: (B)(4). LEGAL MANUFACTURER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE IS THE HOSPITAL HAD USED AN UNAPPROVED POWER SUPPLY, FURTHER MODIFIED IT CREATING INTERMITTENT AC POWER LOSSES, WHICH LIKELY CAUSED THE FREQUENT LOSSES OF AC POWER. THERE WERE NO REPAIRS TO THE ANESTHESIA MACHINES AC POWER COMPONENTS AS ONLY THE NON-GE EXTERNAL POWER STRIP REQUIRED CORRECTION. WHILE THE GE FIELD ENGINEER WAS ON SITE EVALUATING THE DEVICE, THEY IDENTIFIED THAT THE CUSTOMER WAS USING AN UNAPPROVED NON-MEDICAL POWER STRIP TO PROVIDE AC MAINS POWER TO THE ANESTHESIA MACHINE. DURING THEIR INSPECTION OF THE ANESTHESIA MACHINE, THE POWER STRIP UNEXPECTEDLY TURNED OFF WITHOUT ANY SWITCH BEING SELECTED. FURTHER REVIEW OF THE POWER STRIP IDENTIFIED THAT IT HAD BEEN MODIFIED FROM ITS ORIGINAL COMMERCIAL CONDITION TO DIRECTLY CONNECT TO AN ISOLATED PANEL. THE MODIFICATIONS OF THE POWER STRIP CAUSED POOR AND FAULTY CONTACT WHICH INTERRUPTED THE POWER CAUSING THE ANESTHESIA MACHINE TO RUN ON BATTERY. BECAUSE THERE WERE MANY ALARMS, OVER MULTIPLE WEEKS, THE DEVICE'S LOGS ONLY CONTAINED APPROXIMATELY 50 DAYS OF DATA AS THE LOGS HAD BEGUN TO OVERWRITE THE EARLIEST DATA. OVER THE APPROXIMATELY 7 WEEKS, THE LOGS IDENTIFIED 109 AC POWER LOSSES. IT IS LIKELY THAT THE POWER STRIP WAS CAUSING INTERMITTENT LOSSES OF POWER, LEADING TO THE ANESTHESIA MACHINE'S 109 AC MAINS POWER INTERRUPTIONS, THEREBY CAUSING IRREGULAR AND INADEQUATE CHARGING CYCLES. OVER 7 WEEKS OF FAILURES, THERE WERE MULTIPLE FULL DEPLETIONS OF A BATTERY FOR TOO LONG, AS WELL AS INADEQUATE/INCOMPLETE CHARGE CYCLE TIMES, WHICH CAUSED UNDUE STRESS TO THE BATTERY LEADING TO A SHORTENED BATTERY LIFE. (CONTINUED IN BLOCK H11).

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT DEATH AFTER USE OF THE AVANCE CS2. IT WAS REPORTED THAT THE UNIT STOPPED VENTILATION DURING THE CASE. THE ANESTHESIOLOGIST PROCEEDED TO USE AN OXYGEN CYLINDER AND A NON-GE HEALTHCARE PATIENT CIRCUIT, AND PERFORMED CPR FOR 6 MINUTES. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE IN CRITICAL CONDITION. THE FOLLOWING DAY, THE PATIENT REPORTEDLY PRESENTED ARRHYTHMIAS AND CARDIAC ARREST AND DIED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078598 AVANCE CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Male Death