BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA V800

    MDR report key: 12292958 · Received August 9, 2021

    Report

    Report Number
    9611500-2021-00334
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 21, 2021
    Report Date
    May 27, 2022
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    QOV
    PMA / PMN Number
    EUA200143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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 DEVICE WAS USED FOR VENTILATION ON THE PATIENT AND, ACCORDING TO THE USER, TURNED OFF AND RESTARTED ON (B)(6)2021 AT AROUND 20:43 P.M. THE DEVICE HAS BEEN REPLACED. NO PATIENT INJURY REPORTED.

    Additional Manufacturer Narrative · 1

    THE LOG FILE OF THE AFFECTED DEVICE WAS PROVIDED AND ANALYZED. BASED ON THE LOG FILE ANALYSIS IT COULD BE CONFIRMED THAT THE DEVICE PERFORMED AN UNEXPECTED RESTART OF THE VENTILATION UNIT AT 20:43 PM ON THE (B)(6) 2021 WITH CO2 MONITORING RUNNING AT THE SAME TIME. THIS RESTART WAS TRIGGERED BY THE SAFETY SOFTWARE AS A SPECIFIED REACTION ON A DETECTED TIME-OUT IN THE SOFTWARE TASK PROCESSING. 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 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 APPROX. 8 SECONDS UNTIL THE VENTILATION IS AUTOMATICALLY RESUMED WITH THE LATEST SETTINGS. THE RESTART SEQUENCE OF THE ECD MAY TAKES APPROX. 1 MINUTE. IN THE MEANTIME, THE USER CAN OBSERVE THE ALREADY RESUMED VENTILATION AND SAFETY-RELEVANT PARAMETERS ON 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 DEVICE REACTED AS SPECIFIED ON A DETECTED TIME-OUT IN THE SOFTWARE TASK PROCESSING AND TRIGGERED A SYNCHRONIZED RESTART OF THE VENTILATION UNIT AND THE ECD. THE USER WAS NOTIFIED ABOUT THE SITUATION BY AN AUDITORY AND VISUAL ALARM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE RESTART OCCURRED ONCE DUE TO AN ERROR IN THE SOFTWARE WHILE THE INTEGRATED CO2 MONITORING WAS ACTIVATED. RECURRENCE OF THIS SPECIFIC DEVIATION CAN BE AVOIDED BY INACTIVATING THE INTEGRATED CO2 MONITORING. BASED ON THE LOGGED DATA A HARDWARE FAILURE WAS ASSESSED RATHER UNLIKELY. TESTING THE DEVICE ACCORDING TO THE MANUFACTURER¿S TEST SPECIFICATION IS RECOMMENDED PRIOR TO FURTHER USE. NO MEDICAL INTERVENTION OR SERIOUS INJURY WAS REPORTED. DRÄGER BECAME AWARE ABOUT OTHER COMPLAINTS WITH RESPECT TO THE SAME ERROR PATTERN. A DEEPER ANALYSIS OF THE ERROR PATTERN WAS INITIATED. A FSCA HAS BEEN PUBLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED FOR VENTILATION ON THE PATIENT AND, ACCORDING TO THE USER, TURNED OFF AND RESTARTED ON (B)(6) 2021 AT AROUND 20:43 P.M. THE DEVICE HAS BEEN REPLACED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192045 EVITA V800 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown