BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 23298071 · Received October 15, 2025

    Report

    Report Number
    8010042-2025-0001541
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 4, 2025
    Report Date
    October 15, 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
    PK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORTED EVENT HAS BEEN COMPLETED. ACCORDING TO THE RECEIVED INFORMATION IN THE COMPLAINT FORM THE AIR GAS MODULE AND PANEL CIRCUIT BOARD (PCB) WAS DETERMINED DEFECTIVE AND IN NEED OF REPLACEMENT. NO SERVICE REPORT OR LOG FILES HAVE BEEN PROVIDED. 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). SINCE NO INFORMATION WAS PROVIDED ON HOW THE ISSUE WAS SOLVED, THE CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER REF#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE INDICATING POWER ERROR. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004350 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800 07325710000823

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown