BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 17660048 · Received August 31, 2023

    Report

    Report Number
    3002808148-2023-09247
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 6, 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
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H4, 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

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION FROM THE CUSTOMER ARE IN PROGRESS. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE RESULTS OF DEVICE EVALUATION. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE COMPLAINT WAS CONFIRMED AND THERE WAS NO IMAGE DISPLAYED ON THE LCD SCREEN DUE TO A DEFECTIVE PRINTED CIRCUIT BOARD. ALSO, EVALUATION FOUND THE LCD FILTER SCREEN HAD IMPACTS. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE HIGH DEFINITION LCD MONITOR HAD NO FUNCTION. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602357 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown