BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 17745705 · Received September 14, 2023

    Report

    Report Number
    3002808148-2023-09838
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    July 23, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS AND EVALUATED. THE CUSTOMER ALLEGATION WAS CONFIRMED. THE LOSS OF POWER WAS DUE TO CIRCUIT BOARD FAILURE. ADDITIONALLY, IT WAS FOUND THAT THE COATING OF THE SCREEN WAS PEELING. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ON COMPLETION OF INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    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 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE POWER SUPPLY TO THE MONITOR DROPPED OFF SOMETIMES, THE POWER LAMP TURNED OFF AND THE SCREEN WENT BLACK. THE POWER CABLE AND VIDEO CABLE WAS REPLACED; HOWEVER, THERE WAS NO IMPROVEMENT. THE ISSUE WAS FOUND DURING A DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391004 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CV-290 VIDEO SYSTEM CENTER