BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BK ULTRASOUND DEVICE

    MDR report key: 21445724 · Received February 24, 2025

    Report

    Report Number
    MW5166714
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    December 27, 2024
    Report Date
    February 19, 2025
    Manufacturer
    BK MEDICAL APS
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DEAR SIR/MADAM, THIS LETTER IS BEING SENT TO YOU REGARDING AN EVENT THAT WAS REPORTED TO (B)(6) ON DECEMBER 27, 2024. THE REPORTED EVENT WAS THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER WAS ENCOUNTERING ISSUES WHERE THE TILEPRO WOULD TURN ON BUT THE IMAGE WAS NOT DISPLAYING. AN (B)(6) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED THE STAFF VERIFY THE VIDEO OUTPUT OF THE BK ULTRASOUND DEVICE. THE TSE EXPLAINED HOW TO COMPLETE A LOOP BACK TEST ON THE DA VINCI TO DISPLAY A TILEPRO IMAGE. THE REPORTER DISCONNECTED FROM THE CALL TO CONTACT BK ULTRASOUND TECHNICAL SUPPORT TO TROUBLESHOOT THE PRODUCT ISSUE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613043 BK ULTRASOUND DEVICE TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BK MEDICAL APS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown