BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODUCT VYNTUS BODY

    MDR report key: 17824876 · Received September 27, 2023

    Report

    Report Number
    9615102-2023-00137
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    June 27, 2022
    Report Date
    September 27, 2023
    Manufacturer
    VYAIRE MEDICAL GMBH
    Product Code
    JEH
    UDI-DI
    04250892904672
    PMA / PMN Number
    K190853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023 DURING A COMPLAINT SEARCH IT BECAME EVIDENT, THAT THIS COMPLAINT IS A SIMILAR COMPLAINT TO THE REPORTABLE COMPLAINT (B)(4).THE REPORTING DECISION WAS UPDATED ACCORDINGLY. DURING THE REMOTE TROUBLESHOOTING THE MOST PROBABLE SEQUENCE OF EVENTS LEADING TO THE BREAKDOWN OF THE DEVICE WAS IDENTIFIED. THE US SENSOR WAS EITHER NOT PROPERLY SCREWED IN THE FPV OR LOOSENED OVER TIME. THE US SENSOR FELL OFF, WAS FOR A MOMENT CAUGHT BY THE CABLE, BEVOR FINALLY TUMBLING TO THE GROUND. THE CUSTOMER WAS TRAINED TO PROPERLY SCREW THE US SENSOR IN THE FPV AND THE DEVICE WAS REPAIRED ON SITE. THE CAPA INVESTIGATION IDENTIFIED THE FOLLOWING ROOT CAUSE: MISUSE OF THE USS AS A ¿HANDLE¿ TO CHANGE THE SUPPORT ARM POSITION INSTEAD OF USING THE PROPER HANDLE OF THE VYNTUS BODY SUPPORT ARM OR THE SUPPORT ARM ITSELF. THIS MISUSE LOOSENS THE MECHANICAL CONNECTION BETWEEN THE USS AND THE FPV SO IT BECOMES INSUFFICIENT TO HOLD THE USS IN PLACE.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED AND COMPLAINED ABOUT THE FIXATION OF THE US SENSOR. A FALLING US SENSOR CAUSED MOST PROBABLY THE BREAKDOWN OF THE DEVICE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649629 PRODUCT VYNTUS BODY VYNTUS BODY JEH VYAIRE MEDICAL GMBH PRODUCT VYNTUS BODY 04250892904672

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown