BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 21952597 · Received May 2, 2025

    Report

    Report Number
    3002808148-2025-07396
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 21, 2025
    Report Date
    November 26, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: H4, H6, H11. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, NO PROBLEM WAS DETECTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE CUSTOMER TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) VIA PHONE THAT THE VIDEO CABLE TO THE MONITOR WAS DISCONNECTED AND THERE WAS NO VIDEO DETECTED ON SDI 1 INPUT ON THE MONITOR AS HE CONNECTED IT. INVESTIGATION INDICATES THAT INCORRECT CONNECTION OF THE CV-190>SDI OUT 2 SIGNAL TO THE OEV-262H>VIDEO IN WAS DONE BY HIM. INSTEAD, THE CABLE TO THE OEV-262H>SDI 1 WAS INSTRUCTED TO BE CONNECTED BY HIM. IT WAS CONFIRMED BY HIM THAT THE ISSUE WAS RESOLVED. THE DEVICE WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SUBJECT DEVICE PRESENTED NO VIDEO. THE EVENT OCCURRED DURING SET UP / INSPECTION FOR USE BEFORE PATIENT IN ROOM. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935413 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CV-190.