BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 17538133 · Received August 13, 2023

    Report

    Report Number
    3002808148-2023-08317
    Event Type
    Malfunction
    Date Received
    August 13, 2023
    Report Date
    August 25, 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 WAS UNABLE TO BE IDENTIFIED. IT IS LIKELY THAT THE POWER CANNOT BE TURNED ON DUE TO A FAILURE OF THE GROUND 1 BOARD. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S ISSUE OF ¿POWER FAILURE" WAS CONFIRMED AND DUE TO A FAULTY PRINTED CIRCUIT BOARD FAILURE. THE INVESTIGATION IS ONGOING, AND FOLLOW-UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER PROVIDED CLARIFICATION TO THE EVENT DETAILS. THE EVENT (POWER DOES NOT TURN ON) OCCURRED DURING PREPARATION FOR USE AND THE PRE-INSPECTION CHECK WAS UNABLE TO BE COMPLETED. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE HIGH-DEFINITION LCD MONITOR HAD A POWER FAILURE. DURING PREPARATION FOR USE IN AN UNKNOWN PROCEDURE, THE POWER DID NOT TURN ON THE HIGH-DEFINITION LCD MONITOR AND PROCEDURE WAS CANCELLED. NO PROCEDURE WAS UNDERTAKEN. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085211 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown