BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 17297566 · Received July 11, 2023

    Report

    Report Number
    3002808148-2023-06930
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    July 5, 2023
    Report Date
    September 13, 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
    HK
    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 WAS CONFIRMED DEVICE HAD INTERMITTENT POWER ISSUES. THE SPECIFIC CAUSE OF THE POWER ISSUE WAS NOT ESTABLISHED AT THIS TIME. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED, AND AN INITIAL EVALUATION WAS CONDUCTED BY OLYMPUS; HOWEVER, INVESTIGATION IS ONGOING. DURING THE INITIAL EVALUATION, THE USER¿S REPORT WAS CONFIRMED. THE UNIT WAS EXPERIENCING INTERMITTENT POWER FAILURE DURING TESTING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING THE DEVICE EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    DURING THE RECEIPT INSPECTION OF AN OLYMPUS HIGH-DEFINITION LCD MONITOR, IT WAS DISCOVERED THAT THE DISPLAY WAS INTERMITTENTLY UNABLE TO POWER UP AND WOULD AUTO-POWER DOWN SUDDENLY. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921808 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown