BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 17701966 · Received September 7, 2023

    Report

    Report Number
    3002808148-2023-09532
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 7, 2023
    Report Date
    November 15, 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
    JA
    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, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED ALTHOUGH IT CAN BE PRESUMED IT WAS DUE TO BOARD FAILURE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    E1: (B)(6) HOSPITAL. THE DEVICE WAS RETURNED TO OLYMPUS SERVICE CENTER FOR EVALUATION AND THE CUSTOMER'S REPORTED ISSUE WAS CONFIRMED. THE ISSUE OCCURRED DUE TO FAILURE OF G1 CIRCUIT BOARD. ADDITIONALLY, THE EVALUATION REVEALED THE FOLLOWING FINDINGS: SCRATCHES ON THE SCREEN. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE HIGH-DEFINITION LCD MONITOR DOES NOT TURN ON. THE ISSUE WAS OBSERVED DURING PREPARATION FOR USE AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE FACILITY FINISHED THE PROCEDURE WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101501 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown