BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 21976309 · Received May 7, 2025

    Report

    Report Number
    8010042-2025-0000737
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 24, 2025
    Report Date
    May 7, 2025
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710000823
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS FOR HIGH PRESSURE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820549 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800 07325710000823

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown