BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODUCT VYNTUS BODY

    MDR report key: 17828296 · Received September 27, 2023

    Report

    Report Number
    9615102-2023-00138
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    February 14, 2023
    Report Date
    September 27, 2023
    Manufacturer
    VYAIRE MEDICAL GMBH
    Product Code
    JEH
    PMA / PMN Number
    K190853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 8.SEPT.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. A FIELD SERVICE ENGINEER WENT ON SITE AND CHECKED AND REPAIRED THE SYSTEM USING THE FOLLOWING SPARE PARTS: 1 X V-707377, USS MODULE WITH ADAPTER, 1 X V-707389, FPV BLOCK, 1 X V-707392 ASSY HOUSING CLAMP OF FPV, AFTER REPAIR THE DEVICE HAS BEEN CALIBRATED, TESTED, AND WORKS AGAIN AS SPECIFIED. 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 REPORTED THAT THE ULTRASOUND SENSOR FELL DOWN CAUSING A DEFECTIVE ULTRASOUND SENSOR AND FPV. NO PATIENT OR USER WAS HIT BY THE FALLING PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271212 PRODUCT VYNTUS BODY VYNTUS BODY JEH VYAIRE MEDICAL GMBH PRODUCT VYNTUS BODY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown