BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA V800

    MDR report key: 10740553 · Received October 27, 2020

    Report

    Report Number
    9611500-2020-00378
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Report Date
    May 13, 2022
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    QOV
    PMA / PMN Number
    EUA 200143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE AFFECTED EVITA V800 WITH SERIAL NO. (B)(6)WAS BASED ON THE REPORTED EVENT AND ENHANCED LOGFILE ANALYSIS. ADDITIONALLY, THE DEVICE WAS EXAMINED AT THE MANUFACTURER REPAIR SHOP IN LÜBECK AFTER AN ON-SITE INVESTIGATION DIDN'T FIX THE DEVIATIONS. BASED ON THE RESULTS OF THE EXAMINATION, IT WAS DETERMINED THAT THE DEVICE HAD A LOOSE CONNECTION OF THE PRINTED CIRCUIT BOARD (PCB ECD) ADAPTER. THIS CAUSED A LOSS OF CONNECTION OF THE MONITOR TO THE VENTILATION BOX. CONTRARY TO WHAT WAS REPORTED, NO REBOOT OF THE DEVICE COULD BE DETECTED. THE VENTILATION WAS NOT INTERRUPTED. AS A SAFETY FEATURE OF THE SYSTEM, THE SAFETY SOFTWARE ANALYZES AND CHECKS THE PROPER FUNCTIONING OF THE DEVICE. IF THE SAFETY SOFTWARE DETECTS A DEVIATION REGARDING THE DISPLAY, THE SYSTEM EMITS AN ACOUSTIC ALARM TONE. VENTILATION IS NOT AFFECTED BY A DISPLAY FAILURE AND CONTINUES AS SET. SAFETY-RELEVANT PARAMETERS SUCH AS FIO2, MINUTE VOLUME OR AIRWAY PRESSURE ARE SHOWN IN THE ADDITIONAL YELLOW / GREEN OLED DISPLAY, WHERE THE USER CAN SEE THE VENTILATION IN PROGRESS. DURING THE PREVIOUS REPAIR ON SITE, THE EEPROM DATA WAS NOT SAVED FOR THE PCB, SO THAT THE VENTILATION-BOX COULD NOT CORRECTLY RECOGNIZE THE VERSION OF THE DISPLAY. THE ADAPTER WAS REPLACED AND THE DEVICE WAS TESTED ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS WITHOUT ANY FURTHER DEVIATIONS. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED. THE EVENT WAS ASSESSED TO BE NOT REPORTABLE IN ACCORDANCE TO THE EUROPEAN MEDDEV 2.12 REV. 8 AND THE MEDICAL DEVICE REGULATION (MDR 2017/745).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE SHUTS DOWN AND RESTARTS RANDOMLY AND DISPALYS ERROR 14. NO PATIENT CONSEQUENCES REPORTED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW UP-REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHUTS DOWN AND RESTARTS RANDOMLY AND DISPLAYS ERROR 14. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209505 EVITA V800 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA NA NA
    1209517 EVITA V800 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown