BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S BASE UNIT

    MDR report key: 21512878 · Received March 4, 2025

    Report

    Report Number
    8010042-2025-0000346
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 28, 2025
    Report Date
    March 4, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON-SITE INVESTIGATION WAS PERFORMED BY DISTRIBUTOR'S FIELD SERVICE ENGINEER. THE CLAIMED ISSUE WAS REPRODUCED DURING TROUBLESHOOTING. ACCORDING TO RECEIVED INFORMATION IN SERVICE REPORT, THE REPLACEMENT OF THE AIR GAS MODULE SOLVED THE ISSUE. THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS CLEARED FOR CLINICAL USE. THE AIR GAS MODULE REGULATES THE INSPIRATORY GAS FLOW AND A FAULTY AIR GAS MODULE MAY AFFECT THE DELIVERED VOLUME OR GAS MIXTURE (O2/AIR). THE DEVICE'S LOGS AND THE CLAIMED PART WERE NOT PROVIDED FOR FURTHER ANALYSIS. OUR CONCLUSION IS THAT THE REPLACED PART WAS THE CAUSE OF THE FAILURE.

    Additional Manufacturer Narrative · 0

    THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED FLOW TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: 1240482

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330324 SERVO-S BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6640440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown