BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-N

    MDR report key: 8631542 · Received May 22, 2019

    Report

    Report Number
    8010042-2019-00328
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    May 14, 2019
    Report Date
    May 25, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT, WHILE ON A BABY IN PRESSURE REGULATED VOLUME CONTROL (PRVC) MODE, THE VENTILATOR FAILED TO STOP PRESSURE AT 5 CMH2O BELOW THE SET ALARM LIMIT AND ALARMS FOR HIGH PRESSURE WERE GENERATED. THE PRESSURE WAS GOING UP TO THE HIGH PRESSURE ALARM SETTING AND WAS NOT STOPPING AT 5 CMH2O BELOW THE SET PRESSURE LIMIT AS EXPECTED. THERE WAS NO PATIENT HARM. DEVICE LOGS WERE NOT DOWNLOADED BY OUR FIELD SERVICE ENGINEER AS THE VENTILATOR WAS STILL IN USE AT THE TIME OF THE VISIT. THERE IS NO INFORMATION WHEN A SUCCESSFUL PRE-USE CHECK LAST WAS PERFORMED BEFORE THE EVENT. IN PRVC VENTILATION MODE, THE VENTILATOR DELIVERS A PRE-SET TIDAL VOLUME AND THE PRESSURE IS AUTOMATICALLY REGULATED TO DELIVER THE PRE-SET VOLUME WITH THE LOWEST POSSIBLE PRESSURE. THE VENTILATOR ALSO TRIES TO LIMIT THE PRESSURE TO 5 CMH2O BELOW THE SET UPPER PRESSURE LIMIT. A HIGH AIRWAY PRESSURE ALARM MAY STILL BE TRIGGERED IF, FOR INSTANCE, THE PATIENT IS ACTIVE AND WORKING AGAINST THE VENTILATOR BY COUGHING. THIS IS ESPECIALLY TRUE IF THE ALARM LIMIT IS SET WITH A SMALL MARGIN FOR THE CONTROL LIMITATION TO BE ACTIVATED. THE CONCLUSION IN THIS MATTER IS THAT THE REPORTED PROBLEM LIKELY WAS RELATED TO SUB-OPTIMAL PARAMETER SETTINGS OF THE DEVICE FOR THE ACTUAL PATIENT CONDITION, BUT THIS CANNOT BE CONFIRMED. DUE TO LACK OF INFORMATION, THE ROOT CAUSE CANNOT BE DETERMINED. ALARMS WILL BE GENERATED WHEN SET LIMITS ARE EXCEEDED.

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERON: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURING REF. #: 212190.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR HIGH PRESSURE DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. MANUFACTURING REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425920 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1