BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVITA V800

    MDR report key: 14692688 · Received June 15, 2022

    Report

    Report Number
    9611500-2022-00142
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    May 31, 2022
    Report Date
    August 4, 2022
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    QOV
    PMA / PMN Number
    EUA200143
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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, EMAIL CORRESPONDENCE AND AN ON-SITE INSPECTION BY A DRÄGER SERVICE TECHNICIAN. IN ADDITION, THE PROVIDED LOG FILE OF THE AFFECTED EVITA V800 WITH THE SERIAL NUMBER (B)(6) WAS ANALYZED AT THE MANUFACTURER'S SITE IN LÜBECK. DURING THE ON-SITE INSPECTION OF THE DEVICE, NO DEVIATION OR MALFUNCTION OF THE DEVICE COULD BE DETECTED. THE DEVICE WAS CHECKED ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS. THE LOG FILE ANALYSIS REVEALED THAT THE EVITA V800 DID PROMPT VISUAL AND AUDITORY ALARMS AT THE REPORTED TIME OF EVENT (MAY 31TH 2022 AT AROUND 23:26 SYSTEM TIME) INDICATING AN IMPAIRED VENTILATION IN VC-SIMV VENTILATION MODE, SUCH AS "AIRWAY PRESSURE HIGH", "PRESSURE LIMITED" AND "MINUTE VOLUME LOW". FURTHERMORE, THE VENTILATOR REPEATEDLY PERFORMED PRESSURE RELEASES TO THE AMBIENT BY OPENING THE SAFETY VALVE. THE IMPAIRED VENTILATION AND PRESSURE RELEASES MAY BE CAUSED BY THE CLOGGED FLOW SENSOR OUTLET SINCE IT WAS REPORTED THAT THE USER DID ALLEGEDLY CONNECT THE NEBULIZER HOSE ONTO IT. THE USER WAS AWARE AND STOPPED THE VENTILATION BY ENTERING STANDBY MODE ON 23:28 SYSTEM TIME. THE LOG FILE CONTAINED NO ENTRIES INDICATING A FAULTY AUDITORY ALARM SYSTEM OR RESTART OR OTHER TECHNICAL MALFUNCTION OF THE VENTILATOR. THE DEVICE INSTRUCTIONS FOR USE DESCRIBE THE CORRECT POSITIONING AND USE OF THE NEBULIZER. FOR SAFETY REASONS THE SAFETY SOFTWARE MONITORS THE PRIMARY ACOUSTIC ALARM SYSTEM ON TWO CHANNELS FOR PROPER FUNCTION. IN CASE OF A DETECTED DEVIATION WITH RESPECT TO THE PRIMARY ACOUSTIC ALARM SYSTEM, THE ALARM MESSAGE "ALARM SYSTEM FAILED" WILL BE PROMPTED ON THE SCREEN. THE VENTILATION IS NOT AFFECTED BY THAT DEVIATION AND WILL BE CONTINUED AS SET. IN CASE OF AN ADDITIONAL HIGH-PRIORITY ALARM EVENT, THE SECONDARY ACOUSTIC ALARM SYSTEM (PIEZO SPEAKER OF THE VENTILATION UNIT) WILL BE ACTIVATED IN ORDER TO ALERT THE USER TO THE SITUATION. AS PER THE INSTRUCTIONS FOR USE, THE VENTILATION MAY BE CONTINUED BY CLOSELY MONITORING THE FUNCTIONAL INTEGRITY OF THE DEVICE. FOR ERROR CORRECTION OR REPAIR SPECIALIZED SERVICE PERSONNEL NEEDS TO BE CONTACTED. IN SUMMARY, THE REPORTED SYMPTOM OF ALLEGEDLY MISSING AUDITORY ALARMS WAS NOT CONFIRMED. THE COMPLAINT INVESTIGATION DID NOT REVEAL ANY NEW OR ADDITIONAL RISK THAN ALREADY CONSIDERED BY THE DEVICE RISK MANAGEMENT FILE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SUFFERED A CARDIAC ARREST AND THAT THERE WAS A DEVICE ISSUE THAT ALSO DID NOT PROVIDE AN AUDIBLE ALARM. THE PATIENT RECOVERED WITH NO DIRECT ADVERSE EFFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SUFFERED A CARDIAC ARREST AND THAT THERE WAS A DEVICE ISSUE THAT ALSO DID NOT PROVIDE AN AUDIBLE ALARM. THE PATIENT RECOVERED WITH NO DIRECT ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657953 EVITA V800 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening