BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 17306980 · Received July 12, 2023

    Report

    Report Number
    3002808148-2023-07008
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Report Date
    August 23, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS, THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY, THAT [NO LIQUID CRYSTAL DISPLAY (LCD) IMAGE] OCCURRED, DUE TO PRINTED CIRCUIT (QB) BOARD FAILURE. ROOT CAUSES COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AS PART OF THE ASSET RETURN PROCESS. THE DEVICE EVALUATION FOUND THAT THERE WAS NO IMAGE ON SCREEN DUE TO A PRINTED CIRCUIT BOARD FAILURE. ADDITIONALLY, IT WAS FOUND THAT THE BEZEL AND REAR COVER WERE DAMAGED. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 0

    THE HIGH DEFINITION LCD MONITOR WAS RETURNED AS PART OF THE ASSET RETURN PROCESS. DURING ROUTINE INSPECTION OF THE DEVICE BY OLYMPUS, IT WAS FOUND THAT THERE WAS NO IMAGE ON SCREEN DUE TO A PRINTED CIRCUIT BOARD FAILURE. THERE WAS NO PROCEDURAL OR PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771499 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown