BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-C ANESTHESIA SYSTEM

    MDR report key: 20975531 · Received December 19, 2024

    Report

    Report Number
    8010042-2024-0002098
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Report Date
    December 19, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K191027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THIS COMPLAINT HAS BEEN COMPLETED. THE ANESTHESIA SYSTEM WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER. A SUCCESSFUL SYSTEM CHECKOUT WAS PERFORMED AND THE SYSTEM WAS RUN ON A TEST LUNG FOR OVER ONE HOUR WITHOUT ANY DEVIATIONS FOUND. NO PARTS WERE REPLACED. THE SYSTEM DEVICE LOGS WERE SENT FOR EVALUATION. THE EVALUATION OF THE LOGS SHOWS THAT A SUCCESSFUL SYSTEM CHECKOUT WAS PERFORMED PRIOR TO THE EVENT. THE LOG SHOWS THAT ABOUT 23 MINUTES AFTER TREATMENT START, WHEN THE SYSTEM WAS RUNNING IN AUTOMATIC VENTILATION IN VOLUME CONTROL MODE, ALARMS FOR AIRWAY PRESSURE HIGH WERE GENERATED. THE SYSTEM WAS SET TO MANUAL VENTILATION AND THE TECHNICAL ERROR ALARM INDICATING APL PRESSURE EXCEEDED WAS GENERATED. THE SYSTEM WAS SET BACK TO VOLUME CONTROL AND ALARMS INDICATING A HIGH AIRWAY PRESSURE AND A TECHNICAL ERROR INDICATING VENTILATION CONTROL ERROR WERE GENERATED. THE SYSTEM WAS SHUTDOWN (EMERGENCY VENTILATION STARTED). THE SYSTEM WAS RESTARTED, A NEW SUCCESSFUL SYSTEM CHECKOUT WAS PERFORMED. HOWEVER, ONE OF THE SUB TESTS NEEDED TO BE REDONE SEVERAL TIMES BEFORE IT PASSED DUE TO THAT THE MEASURED FLOW WAS TOO LOW. ACCORDING TO THE LOG, THE NEED TO REDO THE SUB TEST WAS DUE TO THAT A TECHNICAL ERROR INDICATING SAFETY VALVE OPEN WAS ACTIVATED AND DEACTIVATED SEVERAL TIMES DURING THE TEST. THE TREATMENT WAS STARTED AGAIN AND WITHIN A FEW MINUTES, ALARMS INDICATING HIGH AIRWAY PRESSURE AND TECHNICAL ERROR INDICATING APL PRESSURE EXCEEDED, VENTILATION CONTROL ERROR AND AIRWAY PRESSURE SENSOR ERROR, WERE GENERATED. THE SYSTEM WAS SHUTDOWN AGAIN. EVALUATION OF THE LOGS CONFIRMS THE REPORTED EVENT. ADDITIONAL INFORMATION RECEIVED FROM OUR FIELD SERVICE ENGINEER STATED THAT ELEVEN DAYS AFTER THIS EVENT, A SECOND EVENT WITH THE SAME FAILURE ON THE ANESTHESIA SYSTEM REPORTED IN THIS COMPLAINT OCCURRED. THE SECOND EVENT IS REPORTED IN MFG REPORT 8010042-2025-0000098. THE INVESTIGATION PERFORMED FOR THE SECOND EVENT FOUND THAT THE SCAVENGING SYSTEM AT THE HOSPITAL INTERMITTENTLY WAS NOT WORKING, AND THE ISSUE WAS RELATED TO THE HOSPITAL GAS SUPPLY. AFTER RECTIFYING THAT ISSUE, THE ANESTHESIA SYSTEM WAS WORKING WITHOUT ANY ERROR. OUR CONCLUSION IS THAT THE REPORTED FAILURE IN THIS COMPLAINT AND THE FAILURE REPORTED IN 8010042-2025-0000098, HAS THE SAME ROOT CAUSE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE ANESTHESIA SYSTEM WAS USED FOR TREATMENT, THERE WAS A STOP OF VENTILATION. FOUR TECHNICAL ERROR CODES INDICATING APL PRESSURE EXCEEDED, VENTILATION CONTROL ERROR, SAFETY VALVE OPEN AND AIRWAY PRESSURE SENSOR ERROR. THERE WAS NO PATENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949871 FLOW-C ANESTHESIA SYSTEM GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB 6887700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown