BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA V800

    MDR report key: 14389362 · Received May 13, 2022

    Report

    Report Number
    9611500-2022-00115
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 29, 2022
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    QOV
    PMA / PMN Number
    EUA 200143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS BASED ON THE REPORTED EVENT AND THE LOGFILE ANALYSIS OF THE AFFECTED EVITA V800 WITH SERIAL NUMBER (B)(6). BASED ON THE LOG FILE, THE REPORTED EVENT COULD BE CONFIRMED. THE FIRST REBOOT OF THE DEVICE OCCURRED ON (B)(6) 2022, 16:49 SYSTEM TIME. THE RESTART OCCURRED SHORTLY AFTER THE DEVICE WAS TURNED ON, WITH THE USER SWITCHING BACK AND FORTH BETWEEN STANDBY AND VENTILATION THREE TIMES. DATA LOGGING STOPPED UNEXPECTEDLY AT 4:50 PM SYSTEM TIME, AND THE NEXT RESTART WAS LOGGED AT 7:43 AM SYSTEM TIME ON APRIL 28, 2022, AFTER THE DEVICE WAS TURNED BACK ON. THEREAFTER, TWO MORE RESTARTS OCCURRED WITHIN A SHORT PERIOD OF TIME WITHOUT PATIENT INVOLVEMENT, WHICH WERE ALERTED AS SPECIFIED, WITH ACCOMPANYING VISUAL AND AUDIBLE ALARMS. ON SITE, A DRÄGER SERVICE TECHNICIAN REPLACED THE USD CARD AND THE PBA M48.3 BOARD AND SENT THEM TO THE MANUFACTURER'S SITE IN LÜBECK FOR DETAILED INVESTIGATION. ANALYSIS OF THE PBA M48.3 REVEALED A HARDWARE FAULT IN THE COMPONENT, WHICH WAS IDENTIFIED AS THE ROOT CAUSE OF THE RESTARTS. THE USD CARDS PROVIDED DID NOT SHOW ANY DEVIATION. AS A SAFETY FEATURE OF THE SYSTEM, THE SAFETY SOFTWARE ANALYZES AND VERIFIES PROPER FUNCTION OF THE DEVICE. IN CASE OF A DETECTED DEVIATION REGARDING OPERATION OF THE VENTILATION UNIT, THE SAFETY SOFTWARE TRIGGERS A SYNCHRONIZED RESTART OF THE VENTILATION UNIT AND THE ECD IN ORDER TO RESET THE SYSTEM TO A SPECIFIED STATE. DURING RESTART SEQUENCE THE VENTILATION IS TEMPORARILY INTERRUPTED, AND THE SAFETY VALVE IS OPENED TO AMBIENT ALLOWING THE PATIENT FOR SPONTANEOUS BREATHING. THE DEVIATION WILL BE INDICATED BY ACTIVATED AUXILIARY AUDITORY ALARM (PIEZO SPEAKER OF THE VENTILATION UNIT). THE RESTART SEQUENCE OF THE VENTILATION UNIT TAKES UP TO A MAXIMUM OF 8 SECONDS UNTIL EVITA V800 AUTOMATICALLY RESUMES THE VENTILATION WITH THE LATEST SETTINGS. FINALLY, THE ALARM MESSAGE "VENTILATION UNIT RESTARTED" WILL BE PROMPTED ON THE SCREEN WITH ACCOMPANYING AUDITORY ALARM AND THE AUXILIARY AUDITORY ALARM CEASES AUTOMATICALLY. THE DEVICE REACTED AS SPECIFIED AND PERFORMED A REBOOT TO SET THE MICRO PROCESSING SYSTEM TO A SPECIFIED STATE AND POSTED THE ALARM MESSAGE "VENTILATION UNIT RESTARTED" TO INFORM THE USER ABOUT THE SITUATION. HOWEVER DUE TO AN EXISTING HARDWARE MALFUNCTION THE REBOOT COULD NOT SOLVE THE ISSUE SUSTAINABLE. FIELD QUALITY DATA ARE MONITORED AND ASSESSED BY THE RESPONSIBLE PRODUCT QUALITY BOARD. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT AFTER 3 MINUTES OF VENTILATION A "REBOOT AFTER SYSTEM ERROR" OCCURRED. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT AFTER 3 MINUTES OF VENTILATION A "REBOOT AFTER SYSTEM ERROR" OCCURRED. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309896 EVITA V800 VENTILATORS, INTENSIVE CARE QOV

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown