BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYNTUS BODY APS

    MDR report key: 24001206 · Received January 8, 2026

    Report

    Report Number
    1000271197-0001-02026
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 11, 2025
    Report Date
    January 8, 2026
    Manufacturer
    JAEGER MEDICAL GMBH
    Product Code
    BZC
    UDI-DI
    04250892908304
    PMA / PMN Number
    K190853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE TO DATE, AN INTERNAL INVESTIGATION WAS INITIATED TO ASSESS THE REPORTED PATIENT REACTIONS AND THE CONCERNS REGARDING NEBULIZER OUTPUT PERFORMANCE DURING BRONCHIAL PROVOCATION TESTING. AS A FIRST STEP, ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER. THIS INCLUDED THE DETAILED BRONCHIAL PROVOCATION PROTOCOLS USED DURING THE AFFECTED TESTS AS WELL AS ANONYMIZED PATIENT RELATED DATA, IN ORDER TO BETTER UNDERSTAND THE TEST CONDITIONS AND ADMINISTERED DOSES. A REVIEW OF THE REPORTED MEASUREMENTS INDICATED VARIABILITY IN NEBULIZER OUTPUT VALUES WHEN DIFFERENT FILLING VOLUMES AND TEST SETUPS WERE USED. AS THE INFLUENCE OF FILLING VOLUME ON NEBULIZER OUTPUT COULD NOT BE EXCLUDED BASED ON THE AVAILABLE DATA, FURTHER CLARIFICATION WAS CONSIDERED NECESSARY. TO OBJECTIVELY ASSESS THIS POTENTIAL INFLUENCING FACTOR, IT WAS DECIDED TO INVOLVE AN EXTERNAL ACCREDITED LABORATORY. THE PURPOSE OF THIS TESTING WILL BE TO EVALUATE WHETHER THE VOLUME OF SOLUTION IN THE NEBULIZER CONTAINER HAS AN IMPACT ON THE MEASURED OUTPUT AND TO WHAT EXTENT THIS MAY AFFECT DOSE DELIVERY DURING USE. THE INVESTIGATION REMAINS ONGOING AND WILL BE UPDATED ONCE THE REQUESTED PROTOCOLS AND THE EXTERNAL LABORATORY RESULTS ARE AVAILABLE. RESULTS OF THE ASSESSMENT: THE MALFUNCTION RESULTED IN A MEDIUM RISK FOR A PATIENT, USER OR 3RD-PARTY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING RECENT HISTAMINE PROVOCATION TESTING USING THE VYNTUS BODY APS SYSTEM, TWO PATIENTS EXPERIENCED DISCOMFORT DURING BRONCHIAL PROVOCATION TESTING WITH HISTAMINE. THE HISTAMINE CONCENTRATION USED WAS 16 MG/ML AND THE PROVOCATION PROTOCOL CONSISTED OF FOUR STEPS OF 0.015, 0.045, 0.18 AND 0.72. ONE PATIENT EXPERIENCED HOT FLUSHES AND DIZZINESS AND DEVELOPED BRONCHOCONSTRICTION WITH A SIGNIFICANT REDUCTION IN FEV, RESULTING IN A POSITIVE BRONCHIAL CHALLENGE RESPONSE. ANOTHER PATIENT DID NOT SHOW BRONCHOCONSTRICTION BUT FAINTED IN THE TEST BOOTH FOR A FEW SECONDS. NO FURTHER SYMPTOMS BEYOND DISCOMFORT, DIZZINESS AND FAINTING WERE REPORTED. IN ADDITION, CONCERNS WERE RAISED REGARDING THE NEBULIZER OUTPUT DURING USE OF THE APS SYSTEM. MEASUREMENTS PERFORMED ON SITE BY THE CUSTOMER USING SALINE SOLUTION AND A PRECISION SCALE INDICATED HIGHER NEBULIZER OUTPUT VALUES THAN EXPECTED BASED ON AVAILABLE TECHNICAL INFORMATION. THIS LED TO UNCERTAINTY REGARDING THE AMOUNT OF SUBSTANCE ADMINISTERED TO PATIENTS DURING BRONCHIAL PROVOCATION TESTING. FURTHERMORE, CONCERNS WERE EXPRESSED ABOUT THE RELIABILITY OF NEBULIZER PERFORMANCE WHEN DIFFERENT FILLING VOLUMES ARE USED. IT WAS NOTED THAT THE NEBULIZER CUP IS GRADUATED UP TO HIGHER VOLUMES, WHICH MAY GIVE THE IMPRESSION THAT ACCURATE AND SAFE ADMINISTRATION IS ENSURED ACROSS THE FULL RANGE, POTENTIALLY LEADING TO USE OUTSIDE THE INTENDED OPERATING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61527 VYNTUS BODY APS WHOLE-BODY PLETHYSMOGRAPHY BZC JAEGER MEDICAL GMBH V-378510 04250892908304

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability| O