BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA V600

    MDR report key: 14140234 · Received April 19, 2022

    Report

    Report Number
    9611500-2022-00097
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 28, 2022
    Report Date
    June 7, 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

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

    Additional Manufacturer Narrative · 0

    THE AFFECTED EVITA V600 WAS CHECKED ON SITE BY DRÄGER SERVICE AND THE LOG FILE WAS SAVED FOR FURTHER ANALYSIS. THE REPORTED WARM STARTS OF THE VENTILATION UNIT IN THE MORNING OF (B)(6) 2022, COULD BE CONFIRMED BASED ON THE LOGBOOK ENTRIES. IN THE INITIAL ON-SITE ANALYSIS OF THE DEVICE, NO MALFUNCTION COULD BE IDENTIFIED. BASED ON THE LOGBOOK ENTRIES, THE PBA M48.3 INCLUDING THE RED AND BLUE USD CARDS WAS REPLACED AS A PREVENTIVE MEASURE. THE FUNCTION TEST AND RAM MEMORY STRESS TEST CARRIED OUT WITH THE CIRCUIT BOARD AND THE USD CARDS IN THE FOLLOWING DID NOT RESULT IN ANY DEVIATION FROM THE SPECIFICATION. ALL LOGGED WARM START PROCESSES WERE RELATED TO A PREVIOUS POWER FAILURE EVENT, THE EXACT CAUSE OF WHICH CANNOT BE DETERMINED CONCLUSIVELY FROM THE LOGBOOK. THE COURSE OF EVENTS INDICATED THAT THE DEVICE WAS REPEATEDLY SWITCHED ON AND OFF (CORRESPONDING TO THE POWER FAILURE EVENT) BY THE USER IN RESPONSE TO ANOTHER PERCEIVED MALFUNCTION. THE "DEVICE MALFUNCTION (14)" ALARM MESSAGE LOGGED BEFORE THE WARM START PROCESSES INDICATES A TEMPORARY DEVIATION IN THE DISPLAY THAT MAY HAVE CAUSED THE USER TO SWITCH THE DEVICE OFF AND ON AGAIN USING THE MAIN SWITCH. SINCE NO MALFUNCTION COULD BE FOUND DURING THE DEVICE ANALYSIS, THE CAUSE OF THE REPORTED DEVICE PROBLEM CANNOT BE CONCLUSIVELY IDENTIFIED. IF THE DEVICE DETECTS A DEVIATION OF THE VENTILATION UNIT, A WARM START OF THE VENTILATION UNIT AND CONTROL PANEL ARE INITIATED AT THE SAME TIME AS A SPECIFIED REACTION. DURING A WARM START, VENTILATION IS TEMPORARILY SUSPENDED AND AUXILIARY AUDIBLE ALARM SOUNDS. MEANWHILE, THE SAFETY VALVE IS OPENED TO AMBIENT TO ALLOW THE PATIENT TO BREATHE SPONTANEOUSLY. AFTER 8 SECONDS AT THE LATEST, VENTILATION IS AUTOMATICALLY RESUMED WITH UNCHANGED SETTINGS. THE WARM START OF THE CONTROL PANEL IS COMPLETED AFTER A MINUTE AT THE LATEST. MEANWHILE, THE USER CAN OBSERVE THE VENTILATION THAT HAS ALREADY BEEN RESUMED VIA THE OLED DISPLAY OF THE VENTILATION UNIT AND READ SAFETY-RELEVANT PARAMETERS SUCH AS FIO2 CONCENTRATION, MINUTE VOLUME AND AIRWAY PRESSURE. THE WARM START FINALLY IS INDICATED BY THE ALARM MESSAGE "VENTILATION UNIT RESTARTED" ON THE CONTROL PANEL WITH AN ACOUSTIC ALARM TONE SEQUENCE. THE NUMBER OF SIMILAR CASES IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE PERFORMED WARMSTARTS DURING USE. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE PERFORMED WARMSTARTS DURING USE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52438 EVITA V600 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown