BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20 ANESTHESIA SYSTEM

    MDR report key: 22473383 · Received July 10, 2025

    Report

    Report Number
    8010042-2025-0001076
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 12, 2025
    Report Date
    July 10, 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

    THE INVESTIGATION OF THE REPORTED FAILURE IN THIS COMPLAINT HAS BEEN COMPLETED. THE SYSTEM WAS INVESTIGATED BY THE DISTRIBUTOR'S FIELD SERVICE ENGINEER (FSE). THE REPORTED ISSUE WAS NOT REPRODUCED. THIS MARKS THE THIRD OCCURRENCE OF THE ISSUE, SEE MFG REPORT NUMBER: 8010042-2025-0000895 AND MFG REPORT NUMBER: 8010042-2025-0000947 FOR THE TWO PRIOR EVENTS. DURING THE FURTHER INVESTIGATION BY THE DISTRIBUTOR'S FSE IT WAS CONFIRMED THAT THE CUSTOMERS CLEANING INTERVAL OF PATIENT CASSETTE IS NOT REGULARLY WHICH IS NOT HOW IT'S RECOMMENDED IN THE CLEANING MANUAL. IT WAS ALSO IDENTIFIED 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 THIS EVENT 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 USEABILITY ISSUE AND THERE'S NO DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE ANESTHESIA SYSTEM WAS USED FOR TREATMENT THE VENTILATION STOPPED AND THE MANUAL BAG WAS NOT FILLING. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855849 FLOW-I C20 ANESTHESIA SYSTEM GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB 6888520 07325710010617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown