BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA V600

    MDR report key: 12486400 · Received September 17, 2021

    Report

    Report Number
    9611500-2021-00392
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    August 3, 2021
    Report Date
    June 1, 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 CARE PROFESSIONAL
    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.

    Additional Manufacturer Narrative · 0

    THE SERVICE REPORT, LOGBOOK AND PBA M48.3 CIRCUIT BOARD, WHICH WAS IDENTIFIED AS THE CAUSE AND REPLACED BY THE DRÄGER SERVICE TECHNICIAN ON SITE IN THE PROCESS OF REPAIRING THE AFFECTED EVITA V800 WITH THE SERIAL NUMBER (B)(6), WERE AVAILABLE FOR THE INVESTIGATION. LOGBOOK ANALYSIS CONFIRMED AN UNEXPECTED RESTART OF THE VENTILATOR UNIT ON 08/03/2021, AT 14:55 SYSTEM TIME, WHICH WAS ALERTED VISUALLY AND AUDIBLY HIGH PRIORITY AS SPECIFIED. THE RESTART WAS TRIGGERED AS A SPECIFIED SAFETY SOFTWARE RESPONSE TO A TIME-OUT IN THE MUTUAL MONITORING OF THE TWO MICROPROCESSORS ON THE PBA M48.3 CIRCUIT BOARD. THE FUNCTIONAL TEST OF THE RETURNED PCB, WHICH WAS PERFORMED BY AN ENGINEERING TEAM IN LÜBECK, CONFIRMED INSTABILITIES OF THE FIRST MICROPROCESSOR UP1 TO EXTERNAL MECHANICAL DISTURBANCES, WHICH CAUSED THE REPORTED ERROR PATTERN. THIS ERROR PATTERN MAY HAVE BEEN CAUSED, FOR EXAMPLE, BY A FAULTY SOLDER CONNECTION OR A COMPONENT DEFECT. THEREFORE, THE REPLACEMENT OF THE PRINTED CIRCUIT BOARD IS CONSIDERED AN EFFECTIVE MEASURE TO ELIMINATE THE REPORTED ERROR PATTERN. FOR SAFETY, THE SAFETY SOFTWARE ANALYZES AND VERIFIES THE CORRECT DEVICE FUNCTION. IF THE SAFETY SOFTWARE DETECTS A DEVIATION OF THE VENTILATION UNIT FROM THE CORRECT DEVICE FUNCTION, IT REQUESTS A WARM START OF THE VENTILATION UNIT AND SIMULTANEOUSLY OF THE CONTROL UNIT AS A SPECIFIED RESPONSE. DURING A WARM START, VENTILATION IS TEMPORARILY INTERRUPTED AND THE ACOUSTIC AUXILIARY ALARM OF THE VENTILATION UNIT SOUNDS. THE SAFETY VALVE IS MEANWHILE OPEN AGAINST THE ENVIRONMENT TO ALLOW THE PATIENT TO BREATHE SPONTANEOUSLY. AFTER 8 SECONDS AT THE LATEST, EVITA V600 AUTOMATICALLY CONTINUES VENTILATION IN UNCHANGED SETTINGS. THE VENTILATOR HAS REACTED ACCORDING TO SPECIFICATION TO A DETECTED DEVIATION IN THE MULTI-CHANNEL MONITORING OF THE MICROPROCESSOR SYSTEM AND HAS PERFORMED A WARM START WITH THE INTENDED VISUAL AS WELL AS AUDIBLE ALARMS. SIMILAR CASES WITH REGARD TO THE PRINTED CIRCUIT BOARD M48.3 AND THE DETERMINED CAUSE OF FAILURE, OF THE FIRST MICROPROCESSOR UP1, HAVE NOT BEEN REPORTED FROM THE FIELD SO FAR. THE NUMBER OF SIMILAR CASES DUE TO THE SAME CAUSE IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND IS THEREFORE ACCEPTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ALARM "DEVICE FAILURE" AND "VENTILATION UNIT RESTARTED" APPEARED WHILE VENTILATION WAS IN PROGRESS. THE UNIT ALARMED. NO PATIENT HEALTH CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ALARM "DEVICE FAILURE" AND "VENTILATION UNIT RESTARTED" APPEARED WHILE VENTILATION WAS IN PROGRESS. THE UNIT ALARMED. NO PATIENT HEALTH CONSEQUENCES WERE 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 ALARM "DEVICE FAILURE" AND "VENTILATION UNIT RESTARTED" APPEARED WHILE VENTILATION WAS IN PROGRESS. THE UNIT ALARMED. NO PATIENT HEALTH CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383459 EVITA V600 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown