BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODUCT VYNTUS BODY

    MDR report key: 17827435 · Received September 27, 2023

    Report

    Report Number
    9615102-2023-00140
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    July 31, 2023
    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
    BE
    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. REMOTE TROUBLESHOOTING HAS BEEN PERFORMED RESULTING IN A DEFECTIVE CABLE AND A DEFECTIVE INTERFACE PCBA BOARD MOST PROBABLY CAUSED BY THE FALL OF THE USS MODULE. V-707698 INTEFACE PCBA BOARD AND V-918067 ASSY CABLE SET USS, FPV / BODY HAVE BEEN SENT TO THE CUSTOMER FOR REPLACEMENT. 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 REPORTING THAT THE BODY CABIN IS NOT RECOGNIZED BY THE SES SOFTWARE. BEFORE THE FAILURE MESSAGE APPEARED THE USS MODULE FELL DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648919 PRODUCT VYNTUS BODY VYNTUS BODY JEH VYAIRE MEDICAL GMBH 04250892904672

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown