BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERSEUS A500

    MDR report key: 22632356 · Received July 28, 2025

    Report

    Report Number
    9611500-2025-00415
    Event Type
    Death
    Date Received
    July 28, 2025
    Date of Event
    June 25, 2025
    Report Date
    August 7, 2025
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BSZ
    UDI-DI
    04048675253600
    PMA / PMN Number
    K133886
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL ON-GOING. THE RESULTS WILL BE PROVIDED WITH A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS PERFORMED BASED ON THE DEVICE LOG FILE. THE CASE IN QUESTION WAS STARTED AT 16:03 USING THE EXTERNAL FRESH GAS OUTLET WITH A FRESH GAS FLOW OF 1.0 L/MIN AND 100 VOL% OXYGEN. IN THE FIRST 6 MINUTES AN ETCO2 BETWEEN 20 AND 36 MMHG WAS MEASURED, THE INSPIRATORY OXYGEN CONCENTRATION WAS - COMPARED TO THE FRESH GAS FLOW SETTING - LOW WITH VALUES BETWEEN 21 AND 38 VOL%. THE DEVICE REPEATEDLY ALARMED FIO2 LOW. NO PRESSURE BUILD-UP WAS RECORDED DURING THE WHOLE PROCEDURE. NO ETCO2 WAS DETECTED IN THE FOLLOWING 10 MINUTES. AT AROUND 16:15, THE INSPIRATORY O2 CONCENTRATION ROSE SHARPLY FROM 21 TO 52 AND THEN UP TO 79 VOL%. BETWEEN 16:19 AND 16:22, AN ETCO2 BETWEEN 8 AND 21 MMHG WAS TEMPORARILY MEASURED, BUT SUBSEQUENTLY FELL BACK TO 0. FURTHERMORE, THE INSPIRATORY OXYGEN CONCENTRATION ALSO FELL TO VALUES BETWEEN 21 AND 25 VOL% - DESPITE AN INTERIM INCREASE IN FRESH GAS FLOW TO 5.5 L/MIN (16:18) AND REPEATED ACTIVATION OF EMERGENCY O2 DOSING. AT 16:35 THE UNIT WAS PLACED IN STANDBY. THE ANALYSIS OF THE DEVICE LOGFILE HAS GIVEN NO HINTS FOR A MALFUNCTION OF THE DEVICE. ACCORDING TO THE RECORDS, THE DEVICE WAS USED IN EXT. CGO MODE. IN THIS CASE THE SET FRESH GAS FLOW IS PROVIDED VIA THE EXTERNAL FRESH-GAS OUTLET. IT IS CONCEIVABLE THAT THE NON-REBREATHING SYSTEM WAS NOT (CORRECTLY) CONNECTED, THE PATIENT WAS CONNECTED TO THE INTEGRATED BREATHING SYSTEM, OR THE WRONG BREATHING BAG (BAG OF THE INTEGRATED BREATHING SYSTEM) WAS USED TO MANUALLY VENTILATE THE PATIENT. THE CORRECT CONNECTION AND USE OF A NON-REBREATHING SYSTEM IS DESCRIBED IN THE INSTRUCTIONS FOR USE OF THE ANESTHESIA MACHINE. IT CONTAINS THE FOLLOWING WARNING: "INSUFFICIENT GAS SUPPLY TO THE PATIENT: NON-REBREATHING SYSTEMS ARE ONLY SUITABLE AND INTENDED FOR MANUAL VENTILATION OR SPONTANEOUS BREATHING AND MAY ONLY BE CONNECTED TO THE EXTERNAL FRESH-GAS OUTLET. WHEN USING A NON-REBREATHING SYSTEM, ENSURE AN ADEQUATE GAS MONITORING." FINALLY, AS NO FURTHER INFORMATION REGARDING THE VENTILATION SETUP WAS PROVIDED (ALTHOUGH REQUESTED) THE EXACT ROOT CAUSE COULDN¿T BE DETERMINED. THE DEVICE ISSUED ADEQUATE ALARMS TO KEEP THE USER INFORMED OF THE CURRENT SITUATION AT ALL TIMES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANAESTHETIC MACHINE IN THEATER 4 COULD NOT FILL UP THE BREATHING BAG WHEN THEY STARTED THE CASE. THE PATIENT REPORTEDLY WAS RESUSCITATED BUT PASSED AWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANAESTHETIC MACHINE IN THEATER 4 COULD NOT FILL UP THE BREATHING BAG WHEN THEY STARTED THE CASE. THE PATIENT REPORTEDLY WAS RESUSCITATED BUT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695246 PERSEUS A500 ANESTHESIA UNITS BSZ DRÄGERWERK AG & CO. KGAA MK06000 04048675253600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death