BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPOR 3000

    MDR report key: 24159522 · Received January 23, 2026

    Report

    Report Number
    9611500-2026-00022
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    December 18, 2025
    Report Date
    January 23, 2026
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CAD
    UDI-DI
    04048675301363
    PMA / PMN Number
    K971923
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO CASE-SPECIFIC EVALUATION COULD BE PERFORMED. DRÄGER BECAME AWARE OF THE INCIDENT WITH THE RECEIPT OF THE UFR; APPROX. 4 WEEKS AFTER THE EVENT. THE CONCERNED VAPORIZER IS OWNED BY PIRAMAL CRITICAL CARE, THE MANUFACTURER OF THE ANESTHETIC AGENT THE DEVICE HAS TO BE USED WITH. WHEN DRÄGER COULD START THE INVESTIGATION, THE VAPORIZER WAS ALREADY REPAIRED BY A THIRD-PARTY SERVICE PROVIDER ACCORDING TO THE CORRESPONDING ORDER FROM THE OWNER. ALTHOUGH THE EXACT ROOT CAUSE COULD NOT DETERMINED, DRÄGER FINALLY CONCLUDES THAT THE RISK WHICH MUST BE ATTRIBUTED TO AN OVERDOSE OF VOLATILE ANESTHETICS IS UNDER CONTROL. PATIENT GAS MONITORING IS MANDATORY FOR ANESTHETIC PROCEDURES ¿ THE ANESTHESIOLOGIST HAS A CONSTANT OVERVIEW OF AGENT DOSAGE AND THE GAS EXCHANGE OF THE PATIENT. IT IS UNDER RESPONSIBILITY AND CONTROL OF THE USER TO SET PATIENT-SPECIFIC ALARM THRESHOLDS TO HAVE AN ADEQUATE RESPONSE TIME IF DEVIATIONS OCCUR. DURING THE PARTICULAR SURGICAL PROCEDURE, THE VAPORIZER WAS MOUNTED TO AN ANESTHESIA WORKSTATION OF TYPE DRÄGER PRIMUS IE. THE WORKSTATION WAS FURTHER USED SINCE THE INCIDENT AND THUS, RELEVANT DATA IN THE LOG FILE IS ALREADY OVERWRITTEN. IT WAS CONFIRMED BY THE USER FACILITY TO DRÄGER THAT THE PRIMUS IE HAS POSTED ALARMS DURING THE COURSE OF EVENT, INDICATING HIGHER READINGS OF THE AGENT IN COMPARISON TO THE SETTINGS. IT IS NOT KNOWN TO DRÄGER IF USER INTERVENTION WAS IMMEDIATELY INITIATED UPON RECOGNITION OF THE ALARMS.

    Description of Event or Problem · 0

    BY MEANS OF AN UFR, DRÄGER WAS NOTIFIED ABOUT AN ADVERSE EVENT OCCURRED DURING USE OF AN ANESTHETIC GAS VAPORIZER OF TYPE DRÄGER VAPOR 3000. A SIGNIFICANT OVERDOSE WAS REPORTEDLY OBSERVED DURING A SURGICAL PROCEDURE; THE PATIENT BECAME BRADYCARDIC AND HYPOTENSIVE, REQUIRING THE ADMINISTRATION OF ATROPINE FOR STABILIZATION. IT WAS MENTIONED THAT NO FINAL HEALTH CONSEQUENCES WERE RESULTING FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221497 VAPOR 3000 ANESTHESIA UNIT VAPORIZERS CAD DRÄGERWERK AG & CO. KGAA M36500 04048675301363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention PRIMUS IE