BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE UNIT SERVO-U

    MDR report key: 17975634 · Received October 20, 2023

    Report

    Report Number
    8010042-2023-02051
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    October 4, 2023
    Report Date
    October 20, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K201874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RELATED DATA QUALITY UPDATES ONLY: THE SERIAL NUMBER FOR THE MEDICAL DEVICE REFERRED TO IN THIS MEDICAL DEVICE REPORT HAS NOT BEEN RECEIVED, AND THEREFORE, NO UDI NUMBER AND MANUFACTURE DATE CAN BE PROVIDED. A CORRECTION OF FIELD # D1 BRAND NAME, # D4 VERSION OR MODEL # WAS REQUIRED. D1 - BRAND NAME: PREVIOUS BRAND NAME: SERVO-U, CORRECTED BRAND NAME: BASE UNIT SERVO-U. D4 - VERSION OR MODEL #: PREVIOUS VERSION OR MODEL #: SERVO-U, CORRECTED VERSION OR MODEL #: 6694800.

    Additional Manufacturer Narrative · 0

    ACCORDING TO PROVIDED INFORMATION, THE CUSTOMER FELT INSECURE WITH THE MEASURED TIDAL VOLUMES DURING TREATMENT WITH NEONATAL AND THAT A Y-SENSOR WAS NOT USED AT THE REPORTED EVENT. PICTURES/SCREENSHOTS AND COMPLETE DEVICE LOGS WERE PROVIDED. ACCORDING TO THE LOG/PICTURE/SCREENSHOT EVALUATED BY OUR SYSTEM ENGINEER, IT WAS NOTED THAT THE I:E SETTING WAS USED, WHICH IS INAPPROPRIATE FOR NEONATAL PATIENTS. THE RECOMMENDATION IS THAT THE USER SHOULD DEFINITELY USE A Y-SENSOR IF THEY ARE UNDER 5ML, ALWAYS RUN PATIENT CIRCUIT TEST IF THE PATIENT CIRCUIT IS CHANGED OR IF ANY LARGE PART IS REMOVED/ADDED TO THE CIRCUIT. INCUBATOR TUBES ARE OK TO REMOVE OR ADD. THERE MUST BE QUITE LARGE PARTS BEING REPLACED. THE TRIGGER FUNCTION WILL BE BETTER WITH THE Y-SENSOR. THEREFORE, THE Y-SENSOR CAN BE GOOD EVEN FOR PATIENTS WHO HAVE LARGER VT THAN 5 ML. WHEN USING OUR PATIENT CIRCUIT AND THE F&P CIRCUIT, THE VALUE IS USUALLY IN ABOUT THE SAME RANGE. IF THE VALUE IS HIGHER, IT IS AN INDICATION THAT THE USER HAS DONE SOMETHING WRONG. AN EXAMPLE IS IF THE PATIENT CIRCUIT TEST IS TESTED WITH THE NEONATAL TEST LOOP CONNECTED JUST TO GET A TIGHT SYSTEM, THEN SUCH A THING CAN GIVE A BEHAVIOR LIKE THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE HAS NOT BEEN ESTABLISHED BY THIS INVESTIGATION. A CORRECTION OF FIELD # D4 UNIQUE IDENTIFIER (UDI) # AND H4 MANUFACTURER DATE WERE REQUIRED. D4 ¿ UNIQUE IDENTIFIER (UDI) # - PREVIOUS UNIQUE IDENTIFIER (UDI) #: MISSING, CORRECTED UNIQUE IDENTIFIER (UDI) #: (B)(4). H4 ¿ MANUFACTURE DATE - PREVIOUS MANUFACTURING DATE: MISSING, CORRECTED MANUFACTURING DATE: 2021-01-26.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR HAD TIDAL VOLUME ISSUE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: 904748.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    MANUFACTURERS REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908536 BASE UNIT SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6694800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown