BEUDAMED
    FDA Adverse Event Death Summary report: N

    DVE/MOVITA

    MDR report key: 24109034 · Received January 19, 2026

    Report

    Report Number
    9611500-2026-00020
    Event Type
    Death
    Date Received
    January 19, 2026
    Date of Event
    December 9, 2025
    Report Date
    March 18, 2026
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    FQO
    PMA / PMN Number
    D167937
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 9/12/2025 DRAEGER POLAND DID RECEIVE AN EMAIL FROM THE CUSTOMER WITH URGENT REQUEST ON DIAGNOSIS AND TECHNICAL CHECK OF TWO DEVICES: PRIMUS (SN: (B)(6) AND MOVITALIFT (SN: (B)(6). NO INFORMATION REGARDING PATIENT IMPACT WAS GIVEN. DRAEGER DOCUMENTED THE FOUND DEVIATION (UNAPPROVED MODIFICATION) AND REPORTED IT BACK TO THE CUSTOMER. THE RESULTS OF THE DRAEGER INVESTIGATION WILL BE PROVIDED IN A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED INCIDENT WAS CAUSED BY AN INCORRECT REPAIR/MAINTENANCE DONE TO THE SUPPLY UNIT IN A WAY THAT THE INTERNAL TUBING¿S FOR O2 AND N2O WERE CROSS CONNECTED, AS CONFIRMED BY THE PICTURES PROVIDED. PICTURES SHOW ALSO THAT NON DRAGER HOSES WERE NEWLY INSTALLED BUT NOT ACCORDING TO THE LABELING IN THE DEVICE. OBVIOUSLY, NO GAS TYPE TEST ACCORDING TO DRAEGER INSTRUCTIONS (AFTER HOSE REPLACEMENT) WAS DONE. ACCORDING TO THE REPORT A COMPANY UNKNOWN TO DRAEGER WAS COMMISSIONED BY THE HOSPITAL TO WORK ON THE AFFECTED MOVITA COLUM ASEE-0266L WITH MEDIADOCKING ASDK-0019 AFTER THE LAST SERVICE OF DRAEGER. LAST DRAEGER SERVICE WAS DONE IN (B)(6) 2024 WITHOUT REPLACING PARTS. THE ERROR PATTERN CAN¿T BE DETECTED DURING THE PRE USE CHECK OF THE ANESTHESIA DEVICE, AS THE GAS TYPE IS NOT TESTED BUT SUPPLY PRESSURE LEVEL. THE ELECTRONIC DEVICE LOGFILE OF THE ANETHESIA DEVICE WAS PROVIDED. THE LOGFILE ANALYSIS REVEALED NO INDICATIONS FOR AN ANESTHESIA DEVICE MALFUNCTION, NEITHER DURING NOR BEFORE OR AFTER THE REPORTED EVENT. BOTH, THE ELEVATED N2O CONCENTRATION AS WELL AS THE LOW FIO2, WERE ALARMED IMMEDIATELY AFTER THE PROCEDURE WAS STARTED. THE PATIENT GAS MEASUREMENT SYSTEM WAS FUNCTIONAL DURING THE WHOLE CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEATH OCCURRED, AND THE CUSTOMER SUSPECTED THE APPLICATION OF AN INCORRECT GAS. THE DEVICE HAS NO UDI AS AN UDI WAS NOT REQUIRED AT THE TIME THE DEVICE WAS MANUFACTURED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEATH OCCURRED, AND THE CUSTOMER SUSPECTED THE APPLICATION OF AN INCORRECT GAS. THE DEVICE HAS NO UDI AS AN UDI WAS NOT REQUIRED AT THE TIME THE DEVICE WAS MANUFACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172036 DVE/MOVITA MEDICAL GAS AND VACUUM SYSTEMS FQO DRÄGERWERK AG & CO. KGAA M35054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death NA.| NA.