BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA V300

    MDR report key: 24144049 · Received January 22, 2026

    Report

    Report Number
    9611500-2026-00021
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    January 9, 2026
    Report Date
    May 20, 2026
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    UDI-DI
    04048675389354
    PMA / PMN Number
    K093633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    EVITA V300 ASPA-0041 WAS MADE AVAILABLE FOR INVESTIGATION AT THE MANUFACTURER'S SITE. THE DEVICE INSPECTION FOUND THE PNEUMATIC COMPARTMENT TO BE THERMALLY DAMAGED. THE HIGHEST THERMAL ENERGY IMPACT WAS LOCATED ON THE UPPER LEFT SIDE OF A PRINTED CIRCUIT BOARD ASSEMBLY BEHIND THE TANK OF THE GAS DOSAGE MODULE (GDM). NEARLY ALL COMPONENTS OF THE PNEUMATIC COMPARTMENT WERE DESTROYED. THE PRESSURE-VOLUME-TEMPERATURE MEASUREMENT MODULE AND ITS METAL SHEET HOUSING WAS FOUND IN PLACE. THE GAS INLET PLATE SHOWED NO VISIBLE IMPERFECTION, SO IT WAS NOT CAUSING AN DEVICE-INTERNAL O2 LEAKAGE. BOTH FILTERS (AIR/O2) AT THE GAS INLET WERE FOUND IN PLACE. HENCE, NO FOREIGN MATERIALS POTENTIALLY CAUSING A BURN COULD HAVE BEEN ENTERED THE DEVICE THROUGH THE CENTRAL AIR/O2 GAS SUPPLY. A SPREAD TO THE ELECTRONIC COMPARTMENT WAS EFFECTIVELY AVOIDED BY THE TECHNICAL DESIGN CONCEPT THAT INCLUDES THE ALUMINUM CHASSIS AND SEALING AGAINST O2 ENRICHMENT, AS WELL AS LIMITING ELECTRICAL POWER. A COMPLETE LOG FILE WAS EXTRACTED FROM THE RETURNED DEVICE. THE LOG FILE WAS ANALYZED WITH THE AIM TO UNDERSTAND THE REPORTED EVENT: THE USER PERFORMED A COMPLETE DEVICE CHECK PRIOR TO THERAPY. THE DEVICE CHECK PASSED SUCCESSFULLY. THE DEVICE VENTILATED THE PATIENT IN VOLUME-CONTROLLED VENTILATION MODE. THE APPLIED FIO2 CONCENTRATION WAS SET TO 100 VOL.% FOR ABOUT 45 MINUTES PRIOR TO THE INCIDENT. THE DEVICE ISSUED SEVERAL ALARMS AT AROUND THE INCIDENT, E.G. "AIRWAY PRESSURE HIGH", "DISCONNECTION?", "VT NOT REACHED", "LEAKAGE", "AIRWAY OBSTRUCTED?", "MV LOW". THE SOFTWARE FUNCTION "ANTI-AIR SHOWER" WAS DISABLED, SO THE DEVICE WAS DELIVERING AN INSPIRATORY GAS FLOW OF 180 L/MIN DURING DISCONNECTION. ON 2026-01-09, 21:14:55 SYSTEM TIME, THE DEVICE ISSUED THE ALARM MESSAGE "DEVICE TEMPERATURE MEASUREMENT FAILED". THIS LOG ENTRY WAS INDICATING THE START OF THE THERMAL EVENT. THE TECHNICAL DESIGN CONCEPT OF THE DEVICE FOR PREVENTING AN IGNITION AND THE SPREAD OF FIRE WAS DOUBLE-CHECKED AND ADDITIONAL IGNITION TESTS OF COMPONENTS INSIDE THE PNEUMATIC COMPARTMENT WERE PERFORMED. EVITA V300 IS DESIGNED AND TESTED IN ACCORDANCE WITH IEC 60601-1:2012 (3RD EDITION), CLAUSE 11.1.2 - "PREVENTION OF IGNITION" SO THAT THE RISK OF IGNITION AND THE SPREAD OF FIRE DUE TO EXCESSIVE TEMPERATURES, ARCING OR SPARKING UNDER NORMAL CONDITION AND SINGLE FAULT CONDITION IS REDUCED TO A MINIMUM. ADDITIONAL IGNITION TESTS OF THE BREATHING GAS TEMPERATURE SENSOR AND LOW-PRESSURE-SERVO-VALVE (LPSV) CONFIRMED NO EVIDENCE FOR A POTENTIAL IGNITION. IN SUMMARY, THE COMPLAINT INVESTIGATION SHOWED NO CLEAR ROOT CAUSE FOR THE REPORTED EVENT. THE INVESTIGATION CONFIRMED NO DEVICE-INTERNAL O2 LEAKAGE, NO INTERNAL OR EXTERNAL IGNITION SOURCE, AND NO FOREIGN MATERIAL CAUSING THE THERMAL DECOMPOSITION. THE INVESTIGATION CONCLUDED THAT THE IMPLEMENTED MEASURES ACCORDING TO IEC 60601-1:2012 (3RD EDITION), CLAUSE 11.1.2 WERE FOUND IN PLACE AND EFFECTIVE. SINCE THE MARKET LAUNCH OF THE DEVICE FAMILY IN 2008, THE INSTALLED BASE INCREASED OVER THE YEARS TO NEARLY 100,000 DEVICES. NO COMPATIBLE CASE HAS BEEN REPORTED DURING THIS PERIOD. A SPECIFIC RISK ASSESSMENT WAS MADE AND REVEALED NO NEW HAZARDS OR HAZARDOUS SITUATIONS WITH REGARD TO THE EXISTING PRODUCT RISK MANAGEMENT FILE. ALL INDIVIDUAL RISKS AND THE OVERALL RISK REMAIN ACCEPTABLE. THERE WAS NO UPDATE OF THE EXISTING PRODUCT RISK MANAGEMENT FILE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE BURNED OUT DURING PATIENT USE. IT WAS REPORTED THAT THE PATIENT SUFFERED SOME BURNS BUT IS NOW IN GOOD HEALTH. NO FURTHER INFORMATION ABOUT THE PATIENT STATUS WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE BURNED OUT DURING PATIENT USE. IT WAS REPORTED THAT THE PATIENT SUFFERED SOME BURNS BUT IS NOW IN GOOD HEALTH. NO FURTHER INFORMATION ABOUT THE PATIENT STATUS WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379275 EVITA V300 VENTILATORS, INTENSIVE CARE CBK DRÄGERWERK AG & CO. KGAA 8420440 04048675389354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown