BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20 ANESTHESIA SYSTEM

    MDR report key: 22201434 · Received June 13, 2025

    Report

    Report Number
    8010042-2025-0000895
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 29, 2025
    Report Date
    June 13, 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). BASED ON THE REPORTED FAILURE TWO PCB WAS PROACTIVELY REPLACED, THE SYSTEM WAS SUCCESSFULLY TESTED AND WAS THEN RELEASED FOR USE. THE REPORTED FAILURE HAS THEN REOCCURRED AT TWO OCCASIONS. THESE TWO EVENTS ARE REPORTED IN MFG REPORT NUMBER 8010042-2025-0000947 AND MFG REPORT NUMBER 8010042-2025-0001076. A COMPLETE SET OF DEVICE LOGS WAS RECEIVED. EVALUATION OF THE LOGS FOR THE REPORTED EVENT SHOWS THAT PRIOR TO AND AFTER THE EVENT A SUCCESSFUL SYSTEM CHECKOUT WAS PERFORMED. ALARMS INDICATION A HIGH AIRWAY PRESSURE WAS TRIGGERED DURING MANUAL VENTILATION AND AUTOMATIC VENTILATION. 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 EVENT. 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 USABILITY ISSUE AND THERE'S NO DEVICE MALFUNCTION.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIA SYSTEM EXPERIENCED INTERMITTENT VENTILATION INTERRUPTIONS DURING TREATMENT, ACCOMPANIED BY A HIGH PEEP ALARM AND OTHER CLINICAL ALARMS IN THE DEVICE LOG. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342973 FLOW-I C20 ANESTHESIA SYSTEM GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB 6888520 07325710010617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown