BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 17393970 · Received July 25, 2023

    Report

    Report Number
    3002808148-2023-07492
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    July 3, 2023
    Report Date
    September 12, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION FOUND THE SCREEN BLACKED-OUT DUE TO DEFECTIVE PRINTED CIRCUIT BOARD. IT WAS ALSO REPORTED THAT THE FRONT PANEL WAS SCRATCHED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 9 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE DEFECTIVE PRINTED CIRCUIT BOARD COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE HIGH DEFINITION LCD MONITOR PRODUCED FLICKERING IMAGE UNDER SERIAL DIGITAL INTERFACE (SDI) IN 1 CHANNEL. THE CUSTOMER WAS NOT UNDER SEDATION AND THERE WERE NO DELAYS. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND A DEFECTIVE PRINTED CIRCUIT BOARD. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636618 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown