BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASE UNIT SERVO-U

    MDR report key: 25135245 · Received May 11, 2026

    Report

    Report Number
    8010042-2026-0000613
    Event Type
    Injury
    Date Received
    May 11, 2026
    Date of Event
    April 26, 2026
    Report Date
    May 11, 2026
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710001110
    PMA / PMN Number
    K201874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING NON-INVASIVE VENTILATION THERE WAS LARGE LEAKAGE AND VENTILATION WAS REPEATEDLY PAUSING. THE PATIENT¿S OXYGEN SATURATION DECLINED TO APPROX. 70%. THE VENTILATOR WAS REPLACED. FINAL PATIENT OUTCOME WAS NO HARM. MANUFACTURER¿S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173562 BASE UNIT SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6694800 07325710001110

    Patients

    Seq Age Sex Outcome Treatment
    1