BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20 ANESTHESIA SYSTEM

    MDR report key: 22370199 · Received July 1, 2025

    Report

    Report Number
    8010042-2025-0001004
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 1, 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 DISTRIBUTOR'S FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE SYSTEM ON-SITE AND CONFIRMED THE ISSUE. THE FSE CLEANED THE ALL THE PRESSURE TRANSDUCER PCBS WHICH INITIALLY RESOLVED THE ISSUE. THE SYSTEM HAS SINCE RETURNED TO NORMAL OPERATION. DEVICE LOGS WERE NOT AVAILABLE FOR ANALYSIS. THE ISSUE REOCCURRED ON (B)(6), WHEN AIRWAY PRESSURE SENSOR ERRORS, PRESSURE TRANSDUCER FAILED, AND ADDITIONAL CLINICAL ALARMS WERE TRIGGERED DURING TREATMENT. THE PROBLEM WAS RESOLVED DURING A SECOND SERVICE VISIT BY REPLACING THE FRESH GAS PRESSURE TRANSDUCER PCB. THE SECOND EVENT IS REPORTED IN MFG REPORT NUMBER (8010042-2025-0001022). OUR CONCLUSION IS THAT THE REPORTED FAILURE WAS DUE TO AN OFFSET DRIFT ON THE PRESSURE SENSOR. THE ROOT CAUSE OF THE DRIFT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIA SYSTEM GENERATED AIRWAY PRESSURE SENSOR ALARMS. THERE WAS NO HARM TO THE PATIENT. 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
    1418440 FLOW-I C20 ANESTHESIA SYSTEM GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB 6888520 07325710010617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown