BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S BASE UNIT

    MDR report key: 23120437 · Received September 23, 2025

    Report

    Report Number
    8010042-2025-0001442
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    February 3, 2025
    Report Date
    September 23, 2025
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON PROVIDED INFORMATION, INSPECTION OF THE DEVICE WAS REQUESTED. THE PRESSURE TRANSDUCER BOARD, EXPIRATORY CHANNEL BOARD, AIR GAS MODULE, AC/DC CONVERTER AND EXPIRATORY CHANNEL CONNECTOR BOARD WERE IDENTIFIED AS DEFECTIVE. PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD MEASURES THE PRESSURE, CONVEYED VIA THE PRESSURE TUBE CONNECTED TO THIS BLOCK BY ITS DIFFERENTIAL PRESSURE TRANSDUCER. WITH DIFFERENTIAL REFERENCE TO THE AMBIENT PRESSURE, THE OUTPUT SIGNAL IS PROPORTIONAL TO THE MEASURED PRESSURE THUS GIVING A LINEAR MEASUREMENT IN THE RANGE -40 CMH2O TO +160 CMH2O. EXPIRATORY CHANNEL BOARD CONTAINS ELECTRONICS INCLUDING MICROPROCESSOR FOR E.G. EXPIRATORY FLOW MEASUREMENT PERFORMED BY THE FLOWMETER INSIDE THE CASSETTE AND ELECTRONIC CONNECTIONS TO AND FROM THE CASSETTE, EXPIRATORY VALVE CONTROL, SAFETY VALVE CONTROL, TEMPERATURE MONITORING AND ALSO HOLDERS AND ELECTRICAL CONNECTORS FOR THE EXPIRATORY AND INSPIRATORY PRESSURE TRANSDUCER BOARDS. THE AC/DC CONVERTER IS A COMPLETE UNIT ADAPTED FOR THE SYSTEM. THE AC/DC CONVERTER CONVERTS THE CONNECTED AC POWER (MAINS POWER) TO THE INTERNAL DC SUPPLY VOLTAGE +12V_AC-DC. MAINS POWER IS SUPPLIED TO THE AC/DC CONVERTER VIA THE MAINS INLET. THE EXPIRATORY CHANNEL CONNECTOR IS A CONNECTOR BOARD, INCLUDING SIGNAL FILTERS. IT IS MOUNTED IN THE EXPIRATORY CASSETTE COMPARTMENT AND CONNECTS TO (B)(4) MOUNTED IN THE EXPIRATORY CASSETTE WHEN THE CASSETTE IS DOCKED TO THE EXPIRATORY CASSETTE COMPARTMENT. THE AIR/O2 GAS MODULE REGULATES THE INSPIRATORY GAS FLOW AND A FAULTY AIR/O2 GAS MODULE MAY AFFECT THE DELIVERED VOLUME OR GAS MIXTURE (O2/AIR). UNFORTUNATELY, HE DEVICE LOGS WERE NOT PROVIDED. THE CAUSE TO THE REPORTED ISSUES HAS NOT BEEN DETERMINED. THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRESSURE TRANSDUCER BOARD, EXPIRATORY CHANNEL BOARD, AIR GAS MODULE, AC/DC CONVERTER AND EXPIRATORY CHANNEL CONNECTOR BOARD WERE DEFECTIVE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: 1222205.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532514 SERVO-S BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6640440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown