BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-C ANESTHESIA SYSTEM

    MDR report key: 20769879 · Received November 25, 2024

    Report

    Report Number
    8010042-2024-0001926
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    November 8, 2024
    Report Date
    November 22, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    UDI-DI
    07325710009765
    PMA / PMN Number
    K191027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANESTHESIA SYSTEM WAS INVESTIGATED AT THE HOSPITAL BY OUR COMPANY FIELD SERVICE ENGINEER. THE OXYGEN SENSOR CALIBRATION WAS CHECKED. THE OXYGEN CONCENTRATION IN THE SUPPLIED GAS MIXTURE AT DIFFERENT OXYGEN CONCENTRATION SETTINGS WAS CHECKED. NO IRREGULARITIES IN THE MEASUREMENT AND SUPPLY OF OXYGEN WERE FOUND. THE APL POTENTIOMETER AND TOUCH SCREEN WERE CALIBRATED. THE DEVICE WAS SUCCESSFULLY TESTED AND WAS RETURNED TO CLINICAL USE. THE REPORTED FIO2: LOW ALARMS AS WELL AS HIGH AIRWAY PRESSURE ALARMS CAN BE VERIFIED IN THE SUPPLIED LOGS. WE HAVE NOT BEEN ABLE TO DETERMINE THE TRUE CAUSE OF THESE CLINICAL ALARMS.

    Description of Event or Problem · 0

    THE ANESTHESIA SYSTEM GENERATED ALARMS FOR LOW FIO2 AND HIGH AIRWAY PRESSURE DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2256919 FLOW-C ANESTHESIA SYSTEM GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB 6887700 07325710009765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown