BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SU-4000U-ARM

    MDR report key: 8037878 · Received November 2, 2018

    Report

    Report Number
    MW5081035
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 16, 2018
    Report Date
    October 22, 2018
    Manufacturer
    KONICA MINOLTA HEALTHCARE AMERICAS INC.
    Product Code
    KPR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON TUESDAY (B)(6) AROUND 1245PM, AN X-RAY TECH WAS OPERATING U-ARM. WHILE USING BUTTONS NEAR TABLET, TO ROTATE THE IMAGE RECEPTOR ((B)(6)) THE UNIT CONTINUED TO ROTATE AFTER RELEASING BUTTON. THE RECEPTOR MOVED UNIT REACHED ITS MECHANICAL STOP. THIS ISSUE IS SIMILAR TO ISSUE REPORTED (B)(6) 2018. AND HAPPENS TO BE SAME MACHINE. TALKED WITH DEPT SUPERVISOR ON (B)(6) 2018 TO SET UP TIME TO COME IN AND REPLACE THE TABLET ASSEMBLY. WAS SET UP FOR FRIDAY (B)(6) 2018. UPON ARRIVAL FOUND THAT REPLACEMENT PART THAT WAS SENT BY KONICA HAD A STUCK BUTTON. AT THIS TIME CONTACTED THE VENDOR TO MAKE THEM AWARE OF ISSUE WITH NEW PART. AFTER A SERIES OF CALLS AND EMAILS, IT WAS DETERMINED THAT KONICA WOULD COME TO TROUBLESHOOT. THEY MADE DECISION TO DISABLE THE SWITCH ASSEMBLY LOCATED AT THE TABLET. THAT WAS DONE TODAY (B)(6) 2018. SIMILAR ISSUE HAPPENED, REPORT FILLED OUT (B)(6) 2018 MACHINE WITH SAME SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873432 SU-4000U-ARM SYSTEM, X-RAY STATIONARY KPR KONICA MINOLTA HEALTHCARE AMERICAS INC. SU-4000

    Patients

    Seq Age Sex Outcome Treatment
    1