BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20 ANESTHESIA SYSTEM

    MDR report key: 22291864 · Received June 19, 2025

    Report

    Report Number
    8010042-2025-0000935
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    June 5, 2025
    Report Date
    June 19, 2025
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    UDI-DI
    07325710010617
    PMA / PMN Number
    K191027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OUR INVESTIGATION INTO THIS COMPLAINT HAS BEEN FINALIZED. THE ANESTHESIA SYSTEM WAS INVESTIGATED BY THE FIELD SERVICE ENGINEER (FSE). THE REPORTED ISSUES COULD NOT BE REPRODUCED. A SYSTEM CHECKOUT AND A FUNCTION CHECK WERE SUCCESSFULLY PERFORMED AND THE ANESTHESIA SYSTEM WAS HANDED OVER IN WORKING CONDITION. A COMPLETE SET OF DEVICE LOGS WAS RECEIVED. THE EVALUATION OF THE RECEIVED LOGS CONFIRMS THE REPORTED ISSUES. CLINICAL ALARMS SUGGESTING THE PRESENCE OF VENTILATION ISSUES IN MANUAL VENTILATION AS WELL AS TECHNICAL ERROR CODE INDICATING A DEVIATION BETWEEN SET AND MEASURED VALUES OF THE ADJUSTABLE PRESSURE LIMIT IN MANUAL VENTILATION WAS VERIFIED. DURING FURTHER INVESTIGATIONS BY THE DISTRIBUTOR'S FSE, IT WAS NOTICED THAT NEW STAFF MEMBERS AT THE CUSTOMER, BEING ACCUSTOMED TO OPERATING AN OLDER ANESTHESIA MACHINE, REQUIRED ADDITIONAL GUIDANCE ON THE PROPER USE AND FEATURES OF OUR ANESTHESIA SYSTEM. THIS TRAINING WAS PROVIDED TO THE NEW STAFF MEMBERS AFTER THE EVENTS. THE CUSTOMER HAD BEEN TRAINED ON THE ANESTHESIA SYSTEM PRIOR TO THESE EVENTS BUT NEW STAFF MEMBERS AT THE CUSTOMER WHO WERE NOT FAMILIAR WITH OPERATING THE ANESTHESIA SYSTEM WERE ADDED LATER. IN CONCLUSION NO PARTS WERE FOUND FAULTY, AND THE ANESTHESIA SYSTEM HAS BEEN HANDED OVER TO THE CUSTOMER IN GOOD WORKING CONDITION. OUR CONCLUSION, BASED ON THE OBTAINED INFORMATION, IS THAT THE REPORTED ISSUE WAS A USABILITY ISSUE AND THERE WAS NO DEVICE MALFUNCTION. THE REPORTED FAILURE HAS REOCCURRED ON TWO ADDITIONAL OCCASIONS. THESE TWO EVENTS ARE REPORTED IN MFG REPORT NUMBER 8010042-2025-0000936 AND MFG REPORT NUMBER 8010042-2025-0000937.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE MANUAL BREATHING BAG DID NOT INFLATE. THE EVENT LOG CONTAINS ALARMS FOR AIRWAY PRESSURE HIGH. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURERS REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639263 FLOW-I C20 ANESTHESIA SYSTEM GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB 6888520 07325710010617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown