BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTSTAR ANESTHESIA WT W/OLL 280

    MDR report key: 23356636 · Received October 22, 2025

    Report

    Report Number
    9611500-2025-00590
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    October 10, 2025
    Report Date
    October 22, 2025
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BZA
    PMA / PMN Number
    K042607
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    BASED ON THE LOG ANALYSIS OF THE ZEUS INVOLVED, THE CASE IN QUESTION COULD BE RECONSTRUCTED. NO INDICATIONS FOR A DEVICE MALFUNCTION BUT FOR AN EXTERNAL LEAKAGE WAS FOUND. ADDITIONAL INFORMATION FURTHER CLARIFIED THAT THE WATER TRAP INSTALLED WITHIN THE PATIENT HOSE SYSTEM OF TYPE "VENTSTAR ANESTHESIA WT W/OLL 280" WAS NOT SEATED CORRECTLY RESULTING IN THE LEAK. IT COULD BE FURTHER RECONSTRUCTED BASED ON THE LOG RECORDS, THAT THE DEVICE PASSED THE SELF-TEST IN THE MORNING OF THE DATE OF EVENT. THE FIRST CASE OF THE DAY WAS PERFORMED WITHOUT ANY PROBLEMS OR DISTURBANCES OF VENTILATION. PRIOR TO THE CASE IN QUESTION HOWEVER, THERE WAS NO SELF- OR LEAK-TEST PERFORMED. THIS WOULD HAVE DETECTED AN EXISTING LEAK. THE IFU ALSO ADVISE THE USER TO PERFORM A LEAK-TEST IF E.G. THE BREATHING HOSES ARE REPLACED FOR A NEW PATIENT. THIS WAS NOT THE CASE HERE. DURING THE CASE IN QUESTION, THE DEVICE ALARMED ACCORDINGLY TO ALERT THE USER (TIDAL VOLUME HIGH, FRESH GAS LOW, APNEA AND TIDAL VOLUME IS NOT ACHIEVED). LEAKAGES ARE DETECTED DURING LEAK- AND SELF-TEST OF THE DEVICE PRIOR TO USE. IN CASE A LEAKAGE OCCURS DURING USE OR IN THE COURSE OF THE REPLACEMENT OF BREATHING HOSES FOR A NEW PATIENT, THE DEVICE WILL ALARM ACCORDINGLY AS IT COULD BE CONFIRMED FOR THE PARTICULAR CASE. THE INTEGRATED PRESSURE-, FLOW- AND PATIENT GAS MONITORING FURTHER ENSURES THAT DEVIATIONS FROM SET/EXPECTED VENTILATION PARAMETERS AS WELL AS GAS CONCENTRATIONS ARE OBVIOUS FOR THE USER AND WILL BE ALARMED DEPENDING ON THE ADJUSTED ALARM LIMITS. DRÄGER FINALLY CONCLUDES THAT THE REPORTED SYMPTOM WAS NOT CAUSED BY A DEVICE MALFUNCTION BUT BY A MAJOR EXTERNAL LEAKAGE CAUSED BY AN INSUFFICIENTLY/INCORRECTLY SEATED WATER TRAP IN THE BREATHING HOSE SYSTEM. FURTHERMORE, IT COULD BE CONCLUDED THAT THE DEVICE WOULD HAVE DETECTED THE LEAK PRIOR TO THE CASE IN QUESTION IF A LEAK-TEST HAD BEEN PERFORMED. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME SYMPTOM (INSUFFICIENTLY SEATED WATER TRAP), IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED. THE FIELD FAILURE RATE IS SUBJECT TO PERMANENT MONITORING BY THE RESPONSIBLE PRODUCT QUALITY BOARD AND IS RATED AS ACCEPTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER SEDATION, VENTILATION IS DIFFICULT. THERE SEEMS TO BE NO PRESSURE IN THE BALLOON. AT SETTING 10MBAR AND 70 MBAR, THE BALLOON CONTINUES TO FEEL THE SAME AS IF IT WERE 10MBAR. THE PATIENT IS THEN INTUBATED, WHICH SUCCEEDS WELL. CHECKING AND DOUBLE-CHECKING THAT THE TUBE IS PROPERLY SEATED, SUCCESSFULLY PERFORMED. PATIENT STARTS HAVING DIFFICULTY BREATHING NO AIR COMES IN, HIGH CAPNO VALUES. AUTOFLOW VENTILATION IS STOPPED. BALLOON DIDN'T DO IT BUT ON THE AMBU VENTILATION GOES. WHEN THE PATIENT IS THEN VENTILATED FOR A SECOND TIME WITH AUTOFLOW, AGAIN NO PRESSURE IS BUILT UP. THE PATIENT ENTERS A RESUSCITATION SETTING WHICH IS ULTIMATELY SUCCESSFUL. THE PROCEDURE IS ABORTED AND THE PATIENT IS TAKEN TO THE ICU. SELF TESTS PERFORMED ARE NOT SUCCESSFUL. THE MOMENT A NEW HOSE SET IS CONNECTED, THE DEVICE PASSES THE SELF-TEST. CLOSER EXAMINATION REVEALS THAT ONE OF THE WATER TRAPS IS SCREWED ON IMPROPERLY. IF THE TEST IS THEN PERFORMED WITH A CORRECTLY MOUNTED WATER TRAP, THE DEVICE PASSES THE SELF-TEST WITHOUT ANY PROBLEMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER SEDATION, VENTILATION IS DIFFICULT. THERE SEEMS TO BE NO PRESSURE IN THE BALLOON. AT SETTING 10MBAR AND 70 MBAR, THE BALLOON CONTINUES TO FEEL THE SAME AS IF IT WERE 10MBAR. THE PATIENT IS THEN INTUBATED, WHICH SUCCEEDS WELL. CHECKING AND DOUBLE-CHECKING THAT THE TUBE IS PROPERLY SEATED, SUCCESSFULLY PERFORMED. PATIENT STARTS HAVING DIFFICULTY BREATHING NO AIR COMES IN, HIGH CAPNO VALUES. AUTOFLOW VENTILATION IS STOPPED. BALLOON DIDN'T DO IT BUT ON THE AMBU VENTILATION GOES. WHEN THE PATIENT IS THEN VENTILATED FOR A SECOND TIME WITH AUTOFLOW, AGAIN NO PRESSURE IS BUILT UP. THE PATIENT ENTERS A RESUSCITATION SETTING WHICH IS ULTIMATELY SUCCESSFUL. THE PROCEDURE IS ABORTED AND THE PATIENT IS TAKEN TO THE ICU. SELF TESTS PERFORMED ARE NOT SUCCESSFUL. THE MOMENT A NEW HOSE SET IS CONNECTED, THE DEVICE PASSES THE SELF-TEST. CLOSER EXAMINATION REVEALS THAT ONE OF THE WATER TRAPS IS SCREWED ON IMPROPERLY. IF THE TEST IS THEN PERFORMED WITH A CORRECTLY MOUNTED WATER TRAP, THE DEVICE PASSES THE SELF-TEST WITHOUT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455609 VENTSTAR ANESTHESIA WT W/OLL 280 BREATHING HOSE, DISPOSABLE BZA DRÄGERWERK AG & CO. KGAA MP02720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention NA.| NA.