BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABYLOG VN800

    MDR report key: 25243170 · Received May 21, 2026

    Report

    Report Number
    9611500-2026-00244
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 21, 2026
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    UDI-DI
    04048675542476
    PMA / PMN Number
    K222207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE DISPLAY ON THE FRONT OF THE DEVICE (OLED, FIO2 & MVE) IS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81780 BABYLOG VN800 ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENT CBK DRÄGERWERK AG & CO. KGAA 8422400 04048675542476

    Patients

    Seq Age Sex Outcome Treatment
    1