BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA XL

    MDR report key: 4992332 · Received July 28, 2015

    Report

    Report Number
    9611500-2015-00149
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    May 31, 2015
    Report Date
    July 29, 2015
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K961687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICAL SERVICE REPRESENTATIVE HAS IDENTIFIED VALVE O2 AND VALVE AIR AS ROOT CAUSE OF THE REPORTED PROBLEM AND REPLACED IT. THE REPLACED VALVES AND THE DEVICE LOG WERE SENT TO THE MANUFACTURER FOR INVESTIGATION. IT WAS FOUND THAT VALVE AIR STUCK SPORADICALLY. THE DEVICE LOG ANALYSIS SHOWS THAT IN ADDITION TO THE REPORTED ERROR MESSAGES THE RESPIRATOR HAD POSTED <<MIXER INOP>>. THIS ERROR MESSAGE <<MIXER INOP>> REVEALS THAT THE RESPIRATOR HAD PERFORMED A WARMSTART. THE WARMSTART HAPPENED DUE TO POLLUTION WITHIN THE BEARING, WHICH CARRIES THE TAPPET OF THE DOSAGE SYSTEM. VERY LIKELY SMALL PARTICLES WERE WASHED INTO THE BEARING, HINDERING THE TAPPET IN ITS MOVEMENT. THUS IT STUCK IN AN ARBITRARY POSITION WITH A NOT CONTROLLED FLOW. THIS WAS THE REASON FOR THE REPORTED ERROR MESSAGES. THE WARMSTART IS ACCOMPANIED BY AUDIBLE ALARMS AND VISUAL INFORM THE USER OF THE STATUS OF THE DEVICE. THE EMERGENCY-BREATHING VALUE OPENS, ALLOWING FOR SPONTANEOUS BREATHING. THE WARMSTART NEEDS APPROXIMATELY 8 SECONDS, THEREAFTER VENTILATION IS CONTINUED WITH THE PREVIOUS SETTINGS. BESIDE THE WARMSTART AIRWAY PRESSURE WAS LIMITED TO THE UPPER AIRWAY PRESSURE ALARM LIMIT AS SET BY THE USER. IF THE AIRWAY PRESSURE REACHES THIS LIMIT, THE RESPIRATOR WILL POST <<AIRWAY PRESSURE HIGH>> AND OPEN THE EXPIRATION VALVE TO RELEASE THE SURPLUS GAS TO AMBIENT. REPLACEMENT OF VALVE AIR AND VALVE O2 HAS FIXED THE REPORTED PROBLEM. THE OVERALL FAILURE RATE OF THE VALVES IS WITHIN THE ACCEPTED RANGE. NO FURTHER MEASURES ARE PLANNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE VENTILATOR ALARMED "AIRWAY PRESSURE HIGH, MV HIGH, PEEP HIGH, VT HIGH AND FLOW MEASUREMENT INOP" ALARMS WHILE IN USE ON PT. IN THE COURSE OF INVESTIGATION IT HAS BEEN RECOGNIZED ON (B)(6) 2015 THAT THE DEVICE HAD PERFORMED A WARMSTART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491335 EVITA XL VENTILATORS, INTENSIVE CARE CBK DRAEGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1