BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 17688342 · Received September 6, 2023

    Report

    Report Number
    3002808148-2023-09423
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 8, 2023
    Report Date
    November 9, 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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H6 AND H10. 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 THE REPORTED ISSUE WAS CAUSED BY A FAULTY PRINTED CIRCUIT BOARD. HOWEVER, THE SPECIFIC CAUSE OF THE FAULTY PRINTED CIRCUIT BOARD WAS NOT ESTABLISHED AT THIS TIME. 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 REPORTED ISSUE ¿NO IMAGE- THE SCREEN IS BLACK WITH THE POWER TURNED ON THE GREEN POWER LIGHT IS ON, AND THE SCREEN IS BLACK¿ WAS CONFIRMED. THE FOLLOWING FINDINGS WERE ALSO NOTED DURING DEVICE EVALUATION: HOUSING HAS DISCOLORATION ON REAR VENTS, COSMETIC WEAR, DISPLAY AND ELECTRONIC BOARDS ARE FAULTY, AND IMAGE QUALITY-DIM LIGHT EMITTING DIODE (LED). THE INVESTIGATION IS ONGOING. 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 REPORTED TO OLYMPUS THAT THE HIGH-DEFINITION LCD MONITOR HAD NO IMAGE- THE SCREEN IS BLACK WITH THE POWER TURNED ON THE GREEN POWER LIGHT IS ON, AND THE SCREEN IS BLACK DURING PREPARATION FOR USE FOR AN UNKNOWN DIAGNOSTIC PROCEDURE. 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
    1056768 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown