BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S BASE UNIT

    MDR report key: 23541906 · Received November 13, 2025

    Report

    Report Number
    8010042-2025-0001652
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 17, 2025
    Report Date
    November 13, 2025
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710001127
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED VENTILATOR WAS INVESTIGATED ON-SITE BY THIRD-PARTY SERVICE PROVIDER, WHO FOUND TRACES OF LIQUID CONTAMINATION INSIDE THE FILTER'S CHAMBER OF THE AIR GAS MODULE. THE DEVICE WAS REPAIRED BY REPLACING THE AIR GAS MODULE. THE AIR GAS MODULE REGULATE THE INSPIRATORY GAS FLOW AND GAS MIXTURE. THE LIQUID CONTAMINATION IN THE AIR GAS MODULE AS PREVIOUS INVESTIGATION HAS SHOWN, HAD AFFECTED THE DELTA PRESSURE TRANSDUCER ON A PRINTED CIRCUIT BOARD INSIDE THE AIR GAS MODULE. THE DELTA PRESSURE TRANSDUCER IS PART OF THE FLOW MEASURING IN THE GAS MODULE. THE FAILURE OF THE DELTA PRESSURE TRANSDUCER LEADS TO INACCURATE GAS FLOW REGULATION WHICH WILL BE DETECTED DURING PRE-USE CHECK AND ALARMS WILL BE ACTIVATED IF THE FAILURE OCCURS DURING VENTILATION. THE CONCLUSION IS THAT THE DEVICE DID NOT FAIL TO MEET ITS SPECIFICATION, AS THE MOST PROBABLE SOURCE OF LIQUID CONTAMINATION IN THE AIR GAS MODULE IS A CONTAMINATED AIR GAS FROM THE HOSPITAL'S EXTERNAL COMPRESSOR. ACCORDING TO THE APPLICABLE USER'S MANUAL, MAXIMUM LEVELS OF WATER (H2O < 7 G/M3) IN THE SUPPLIED GASES TO THE VENTILATOR MUST NOT BE EXCEEDED. THIS EVENT IS RELATED TO MDR#: 8010042-2025-0001651 FOR THE COMPRESSOR MINI (DEFECTIVE DRAINAGE VALVE). THE COMPRESSOR MINI SUPPLIED MOIST AIR THAT CAUSED THE VENTILATOR¿S GAS MODULE TO FAIL.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR STOPPED WORKING AND THE PATIENT WAS NOT VENTILATED. FINAL PATIENT OUTCOME WAS NO HARM. MANUFACTURER¿S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923274 SERVO-S BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6640440 07325710001127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown COMPRESSOR MINI 115V 60HZ, SERIAL NUMBER (B)(6).