BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K UHD LCD MONITOR

    MDR report key: 21108075 · Received January 8, 2025

    Report

    Report Number
    3002808148-2025-00528
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 9, 2024
    Report Date
    July 31, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    GCJ
    PMA / PMN Number
    K220069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: D8, G3, H2, H3, H4, H6, H11. THE DEVICE WAS NOT RETURNED TO OLYMPUS, BUT REPORTED IMAGE NOT COMING ON SCREEN FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE ISSUE OCCURRED DUE TO CONFIGURATIONAL MALFUNCTION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT OIP IMAGE NOT COMING UP ON THE MONITOR. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537166 4K UHD LCD MONITOR MONITOR GCJ SHIRAKAWA OLYMPUS CO., LTD. OEV321UH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown