BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYNTUS BODY PC

    MDR report key: 19663740 · Received July 3, 2024

    Report

    Report Number
    9615102-2024-00151
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    January 16, 2024
    Report Date
    November 7, 2024
    Manufacturer
    VYAIRE MEDICAL GMBH
    Product Code
    JEH
    UDI-DI
    04250892904689
    PMA / PMN Number
    K190853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION ABOUT THE INCIDENT IS NOT COMPREHENSIBLE. THE CUSTOMER WAS ASKED TO ASSIST WITH UNDERSTANDING THE INCIDENT BUT HAS NOT ANSWERED TO DATE. THE RISK WILL BE EVALUATED AS SOON AS FURTHER INFORMATION ARE AVAILABLE AND A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE INFORMATION ABOUT THE INCIDENT IS NOT COMPREHENSIBLE. THE CUSTOMER WAS ASKED TO ASSIST WITH UNDERSTANDING THE INCIDENT BUT HAS NOT ANSWERED TO DATE. THE RISK WILL BE EVALUATED AS SOON AS FURTHER INFORMATION ARE AVAILABLE AND A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    VYAIRE WAS INFORMED ON THE 20-MAY-2024 BY THE FDA THAT THE CUSTOMER REPORTED THIS INCIDENT UNDER THE REFERENCE NUMBER (B)(4). THE CUSTOMER REPORTED THE FOLLOWING: "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."

    Description of Event or Problem · 0

    THIS REPORT WAS DUE ON 20-JUL-2024, BUT WAS SUBMITTED LATE DUE TO AN SOFTWARE ERROR. THIS WAS NOTICED AFTER RECEIVING THE DENIED ACKNOWLEDGEMENT AND THE DATE OF THIS REPORT WAS CHANGED TO THE 11-JUL-2024. VYAIRE WAS INFORMED ON THE 20-MAY-2024 BY THE FDA THAT THE CUSTOMER REPORTED THIS INCIDENT UNDER THE REFERENCE NUMBER (B)(4). THE CUSTOMER REPORTED THE FOLLOWING: "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
    526344 VYNTUS BODY PC PLETHYSMOGRAPH, VOLUME JEH VYAIRE MEDICAL GMBH VYNTUS BODY PC 04250892904689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown