BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 24107878 · Received January 19, 2026

    Report

    Report Number
    8010042-2026-0000044
    Event Type
    Malfunction
    Date Received
    January 19, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 19, 2026
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710000823
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO PROVIDE UPDATED INFORMATION IDENTIFIED DURING THE ONGOING INVESTIGATION. AT THE TIME OF THE INITIAL MDR SUBMISSION, IT WAS NOT KNOWN THAT THE DEVICE INVOLVED WAS A VENTILATOR INTENDED FOR USE IN HYPERBARIC OXYGEN THERAPY (HBO) WITHIN A HYPERBARIC CHAMBER. SUBSEQUENT REVIEW HAS DETERMINED THAT THE DEVICE WAS IN FACT A SPECIALIZED VENTILATOR USED DURING HBO TREATMENT. THIS VENTILATOR IS NOT APPROVED FOR MARKETING IN THE UNITED STATES AND DOES NOT HAVE A 510(K) CLEARANCE ON FILE WITH THE FDA. THE USE OF THIS DEVICE IN A HYPERBARIC SETTING WAS NOT INITIALLY DISCLOSED OR IDENTIFIED, AND THIS INFORMATION ONLY BECAME AVAILABLE AFTER FURTHER INQUIRY AND COMMUNICATION WITH THE REPORTING SITE.

    Description of Event or Problem · 0

    MANUFACTURER'S REF. #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621235 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800 07325710000823

    Patients

    Seq Age Sex Outcome Treatment
    1