BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA V800

    MDR report key: 16361548 · Received February 13, 2023

    Report

    Report Number
    9611500-2023-00059
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    September 1, 2022
    Report Date
    March 31, 2023
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    QOV
    PMA / PMN Number
    EUA200143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS BASED ON THE LOG FILE AND THE ANALYSIS OF THE AFFECTED HARDWARE COMPONENTS. THE REPORTED DEVICE BEHAVIOUR COULD BE REPRODUCED. THE HARDWARE ANALYSIS REVEALED THAT THE ACTIVATION OF THE INRUSH CURRENT LIMITATION OF THE FUSE ON THE PRINTED CIRCUIT BOARD OF THE LC DISPLAY LED TO A DARK BACKLIGHT OF THE LC DISPLAY. THE ACTIVATION OF THIS FUSE WAS TRACED BACK TO ADVERSE TOLERANCES TOLERANCE OF THE ELECTRONIC COMPONENTS ON THE ADAPTER BOARD OF THE DISPLAY UNIT OF THE DEVICE. IN CASE THIS FUSE IS ACTIVATED, THE DISPLAY UNIT BOOTS UP, BUT THE GRAPHIC ELEMENTS ON THE DISPLAY ARE ONLY PARTIALLY VISIBLE DUE TO THE FAILURE OF THE BACK LIGHT. THE OPERATION OF THE VENTILATOR BY THE USER IS LIMITED DUE TO THE HARDLY VISIBLE GRAPHICS. HOWEVER, ANY ACTIVE VENTILATION WOULD NOT BE AFFECTED BY THIS ISSUE. THE INRUSH CURRENT LIMITATION OF THE FUSE HAS ALREADY BEEN INCREASED IN ODER TO REMEDY THIS ISSUE. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREEN OF THE DEVICE REPEATEDLY GOES BLACK. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREEN OF THE DEVICE REPEATEDLY GOES BLACK. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388849 EVITA V800 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown