BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYAIRE

    MDR report key: 19350560 · Received May 20, 2024

    Report

    Report Number
    19350560
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    January 16, 2024
    Report Date
    January 18, 2024
    Manufacturer
    VYAIRE MEDICAL GMBH
    Product Code
    BZC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SOFTWARE MALFUNCTIONED ON OUR VYAIRE VYNTUS BODY BOX IN LAB, AND COULD NOT GET SPIROMETRY TESTING SCREEN TO PULL UP. TEST IS STRICTLY TIMED, SO THREW OFF TESTING ACCURACY AND LED TO MEDICATION NEEDING TO BE ADMINISTERED AGAIN ONCE GLITCH WAS FIXED BEFORE WE COULD CONTINUE. SOFTWARE UPGRADE NEEDED AS SOON AS POSSIBLE. DIFFERENT PROBLEMS CONTINUE TO PRESENT THEMSELVES ON DIFFERENT PARTS OF TESTING ON A MORE AND MORE FREQUENT BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161481 VYAIRE CALCULATOR, PULMONARY FUNCTION DATA BZC VYAIRE MEDICAL GMBH 42503370 90029548

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male