BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-U

    MDR report key: 16434058 · Received February 24, 2023

    Report

    Report Number
    8010042-2023-00397
    Event Type
    Death
    Date Received
    February 24, 2023
    Date of Event
    December 30, 2022
    Report Date
    February 24, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K201874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION OF "DATE OF EVENT".

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER. THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THE FAILURE WAS DUE TO THE EXPIRATORY CASSETTE HAD CONDENSATION BUILT UP AND NEEDED CLEANING. THE CONDENSATION IS MOST LIKELY REMNANTS FROM CLEANING WHERE THE EXPIRATORY CASSETTE HAS NOT BEEN DRIED SUFFICIENTLY AND THIS WILL BE DETECTED DURING PRE-USE CHECK. THE EXPIRATORY CASSETTE IS A MEASURING DEVICE ONLY AND WILL NOT AFFECT ONGOING VENTILATION AND NEEDS TO BE CLEANED BETWEEN PATIENTS. IT CAN BE EXCHANGED BETWEEN DIFFERENT VENTILATOR SYSTEMS SO IT IS UNKNOWN IF THIS PARTICULAR EXPIRATORY CASSETTE WAS IN USE ON THE SUBJECTED VENTILATOR DURING THE REPORTED EVENT. AFTER CLEANING OF THE EXPIRATORY CASSETTE, A FULL PREVENTIVE MAINTENANCE WAS PERFORMED AND THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS CLEARED FOR CLINICAL USE. PROVIDED VENTILATOR LOGS WAS REVIEWED. THE EVENT LOG SHOWED LOG POSTS FOR A NORMAL STANDBY MODE ON THE REPORTED EVENT DATE 30/12/2022; STANDBY BUTTON ACTIVATED, STANDBY DIALOG CONFIRMED AND STANDBY: ON (B)(6) 2022 21:28:38, FUNCTIONS, STANDBY, ON (B)(6) 2022 21:28:38, FUNCTIONS, STANDBY DIALOG CONFIRMED, ON (B)(6) 2022 21:28:38, FUNCTIONS, STANDBY BUTTON ACTIVATED. THERE IS A ¿TAP AND HOLD¿ FUNCTION BEFORE ENTERING STANDBY MODE AND THIS ELIMINATES ANY UNINTENTIONAL PRESSING OF THE BUTTON ON THE SCREEN. FIRST THE USER TAP STANDBY IN THE QUICK MENU, THEREAFTER TAP AND HOLD STOP VENTILATION FOR APPROXIMATELY 5 SECONDS TO STOP VENTILATION. THEN THE POSTS FOR A NORMAL STANDBY; STANDBY BUTTON ACTIVATED, STANDBY DIALOG CONFIRMED AND STANDBY ARE LOGGED IN THE EVENT LOG. THIS IS AN INDICATION THAT THE SETTING OF THE VENTILATOR TO STANDBY MODE WAS INTENTIONAL. WHEN THE VENTILATOR IS SET TO STANDBY, THE INDICATION ¿STANDBY, PATIENT NOT VENTILATED¿ IS CLEARLY VISIBLE ON THE SCREEN AND NO WAVEFORMS OR MEASURED VALUES ARE PRESENTED. THE SETTING OF THE VENTILATOR TO STANDBY MODE IS AN ACTIVE OPERATION BY THE USER AND VENTILATION MUST BE STARTED MANUALLY FROM STANDBY MODE. THE VENTILATOR CANNOT SET ITSELF TO STANDBY MODE. THE EVENT LOG ALSO SHOWED THAT THE LAST ALARM 3 MINUTES PRIOR THE VENTILATOR WAS SET TO STANDBY WAS HIGH RESPIRATORY RATE, WHICH INDICATES THAT THE UNIT WAS VENTILATING AT THAT TIME. THE TECHNICAL LOG DOES NOT CONTAIN ANY TECHNICAL ERROR CODES TO INDICATE THAT THERE WAS A VENTILATOR MALFUNCTION AT THE DATE OF THE EVENT. IN THE TEST LOG IT WAS NOTED THAT THE LAST SUCCESSFUL PRE-USE CHECK WAS PERFORMED ON (B)(6) 2022. IT IS UNKNOWN IF THE SAME PATIENT HAS BEEN VENTILATED ON THE SUBJECTED VENTILATOR SINCE THAT TIME. THE CONCLUSION IS THAT THERE WAS NO VENTILATOR MALFUNCTION AT THE REPORTED DATE OF THE EVENT. THE REPORTED STOP OF VENTILATION COULD NOT BE CONFIRMED. HOWEVER, ACCORDING TO THE PROVIDED LOGS THE VENTILATOR HAS BEEN ACTIVELY SET TO STANDBY MODE BUT BY WHOM OR FOR WHAT PURPOSE IS UNKNOWN.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR STOPPED VENTILATING WHILE ON PATIENT. PATIENT DEATH. ALARMS THAT INDICATE INSUFFICIENT VENTILATION BUT NO INDICATION OF A VENTILATOR MALFUNCTION. MANUFACTURER'S REF.#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023667 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-U

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death