BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABYLOG VN600

    MDR report key: 23655514 · Received November 26, 2025

    Report

    Report Number
    9611500-2025-00653
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 26, 2025
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    QOV
    UDI-DI
    04048675551713
    PMA / PMN Number
    K222207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOG FILE OF THE AFFECTED DEVICE WAS MADE AVAILABLE AND ANALYSED. THE LOG FILE SHOWS THAT THE DEVICE GENERATED, A 'DEVICE FAILURE (14)' ALARM AND THE DERIVED ¿ALARM SYSTEM FAILED¿ ALARM ON THE (B)(6) 2025. ANOTHER 'DEVICE FAILURE (14)' ALARM WAS LOGGED FOR THE (B)(6) 2025, WHICH HOWEVER OCCURRED DURING THE DEVICE START-UP PROCEDURE WHILE THE DEVICE HAD NOT YET BEEN USED ON A PATIENT. THE 'DEVICE FAILURE (14)' ALARM WAS CAUSED BY A TEMPORARILY IMPAIRED INTERNAL HDBASET COMMUNICATION BETWEEN THE DISPLAY UNIT (ECD) AND THE VENTILATION UNIT. THIS SYMPTOM IS CHARACTERISTIC FOR A TEMPORARY DISRUPTION OF THE ELECTROMECHANICAL CONTACT BETWEEN THE SYSTEM CABLE AND PBA SYSCON ECD OR A FAULTY SYSTEM CABLE. IF NOT YET DONE THE SYSTEM CABLE AND PBA SYSCON ECD NEED TO BE CHECKED FOR PROPER FITMENT AND TO BE RESEATED IF NECESSARY. IF THE ISSUE RE-OCCURES IT IS RECOMMENDED TO REPLACE THE SYSTEM CABLE. IN CASE OF AN IMPAIRED INTERNAL HDBASET COMMUNICATION BETWEEN THE VENTILATION UNIT AND THE ECD THE ALARM MESSAGE 'DEVICE FAILURE (14)' WILL BE RAISED. THE VENTILATION WILL BE NOT AFFECTED AND CONTINUED AS SET. THE DISPLAY FUNCTIONS AND OPERABILITY OF THE ECD MIGHT BE AFFECTED IN CASE OF AN ACTIVE 'DEVICE FAILURE (14)' ALARM EVENT DEPENDING ON THEN TECHNICAL ROOT CAUSE. IF THE INTERNAL HDBASET COMMUNICATION FAILS COMPLETELY, THE SECONDARY ALARM (PIEZO SPEAKER) OF THE VENTILATION UNIT WILL SOUND. SAFETY RELEVANT PARAMETERS AS FIO2, MINUTE VOLUME AND AIRWAY PRESSURE ARE DISPLAYED ON THE SUPPLEMENTAL OLED-DISPLAY WHEREIN THE USER CAN OBSERVE THE ONGOING VENTILATION. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 'DEVICE ERROR 14' OCCURRED ON (B)(6) 2025. ON (B)(6) 2025, A 'DEVICE FAILURE 14' WAS POSTED AGAIN. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2811968 BABYLOG VN600 VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC QOV DRÄGERWERK AG & CO. KGAA 8422200 04048675551713

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown