BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA V600

    MDR report key: 11782625 · Received May 6, 2021

    Report

    Report Number
    9611500-2021-00195
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 17, 2021
    Report Date
    May 31, 2022
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    QOV
    PMA / PMN Number
    EUA200143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROVIDED LOG FILE WAS INVESTIGATED WITH RESPECT TO THE REPORTED ISSUE. ALSO, A HARDWARE ANALYSIS OF THE RETURNED PBA M48.3 AT THE MANUFACTURER SITE WAS PERFORMED. THIS INCLUDED A FUNCTIONAL TEST, MEMORY TEST AND ENDURANCE TESTING USING AN INDEPENDENT LABORATORY VENTILATOR AND EXTENDED DEBUG LOGGING TOOL. THE THREE REPORTED REBOOTS OF THE EVITA V600 WITH THE SERIAL NO. ASNK-0407COULD BE CONFIRMED AT THE REPORTED TIME. THE DEVICE REACTED AS SPECIFIED WITH AN ACCOMPANYING AUDITORY AND VISUAL ALARM. THE HARDWARE INVESTIGATION OF THE RETURNED PBA M48.3 CONFIRMED AN INDIVIDUAL HARDWARE FAULT OF THE FIRST MICROPROCESSOR WHICH HAD CAUSED THE OBSERVED RESTARTS ACCORDING TO THE DEVICE SAFETY CONCEPT. THIS INDIVIDUAL HARDWARE FAULT BECOME KNOWN FOR THE FIRST TIME FROM THE FIELD. 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 V600 AUTOMATICALLY RESUMES THE VENTILATION WITH THE LATEST SETTINGS. THE RESTART SEQUENCE OF THE ECD MAY TAKE UP TO A MAXIMUM OF 1 MINUTE. IN THE MEANTIME, THE USER CAN OBSERVE THE ALREADY RESUMED VENTILATION AND SAFETY-RELEVANT PARAMETERS SUCH AS FIO2 CONCENTRATION, MINUTE VOLUME AND AIRWAY PRESSURE IN THE OLED-DISPLAY OF THE VENTILATION UNIT. 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 REPLACEMENT OF PBA M48.3 BY DRÄGER SERVICE HAD FIXED THE ISSUE. THE DEVICE WAS TESTED ACCORDING TO MANUFACTURER SPECIFICATION WITHOUT FURTHER DEVIATIONS. THE RESULTS OF THE INVESTIGATION DID NOT REVEAL ANY NEW RISKS WHICH ARE NOT YET COVERED BY THE PRODUCT RISK MANAGEMENT FILE. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

    Additional Manufacturer Narrative · 0

    DUE TO A TECHNICAL ISSUE WITH OUR INTERNAL EMDR SYSTEM WE SUBMITTED FOR THE FORM FDA 3500A AN INCORRECT VALUE FOR THE FIELD H3. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AFFECTED DEVICE MADE 3 TIMES REBOOT DURING VENTILATION. THE DEVICE ALARMED. NO PATIENT HEALTH CONSEQUENCES HAD BEEN REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AFFECTED DEVICE MADE 3 TIMES REBOOT DURING VENTILATION. THE DEVICE ALARMED. NO PATIENT HEALTH CONSEQUENCES HAD BEEN REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AFFECTED DEVICE MADE 3 TIMES REBOOT DURING VENTILATION. THE DEVICE ALARMED. NO PATIENT HEALTH CONSEQUENCES HAD BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684196 EVITA V600 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA NA NA
    684199 EVITA V600 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NA.| NA.| NA.