BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA V800

    MDR report key: 14754021 · Received June 21, 2022

    Report

    Report Number
    9611500-2022-00151
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    June 4, 2022
    Report Date
    October 13, 2022
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    QOV
    UDI-DI
    04048675542148
    PMA / PMN Number
    EAU200143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 LOG FILE OF THE AFFECTED DEVICE WAS ANALYSED FOR INVESTIGATION. BASED ON THE LOG FILE AN UNEXPECTED, SYNCHRONIZED RESTART OF THE VENTILATION UNIT AND THE DISPLAY UNIT ON THE DATE OF EVENT COULD BE CONFIRMED. THE RESTART WAS INITIATED IN REACTION TO A RAM MEMORY CORRUPTION. THE PRINTED CIRCUIT BOARD USED AS THE CENTRAL PROCESSING UNIT TO CONTROL AND MONITOR THE DEVICE WAS REPLACED AND SEND IN FOR DETAILED EXAMINATION. THE REPLACED PART WAS UNDERGOING A FUNCTIONAL TEST AND RAM MEMORY STRESS TEST AS WELL AS AN ENDURANCE TEST IN AN INDEPENDENT LABORATORY VENTILATOR FOR 29 DAYS. THESE TESTS REVEALED NO DEVIATION FROM THE SPECIFICATION. A RESTART OF THE DEVICE COULD NOT BE REPRODUCED DURING THE ENDURANCE TEST. CONSEQUENTLY, THE ROOT CAUSE OF THE IDENTIFIED RAM MEMORY CORRUPTION COULD NOT BE CONCLUSIVELY CLARIFIED. THE DEVICE REACTED AS SPECIFIED ON DETECTING A RAM MEMORY CORRUPTION BY TRIGGERING A SYNCHRONIZED RESTART OF THE VENTILATION UNIT AND THE DISPLAY UNIT 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 THE AMBIENT ALLOWING THE PATIENT TO BREATHE SPONTANEOUSLY. THE DEVICE ALERTED THE SITUATION AS INTENDED AND RESUMED THE VENTILATION AFTER RESTARTING WITH THE LAST SETTINGS. IN THIS CASE NO PATIENT CONSEQUENCES WERE REPORTED. 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 THE UNIT RESTARTED ON A PATIENT. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNIT RESTARTED ON A PATIENT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017232 EVITA V800 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA NA NA 04048675542148

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown