BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 17733392 · Received September 12, 2023

    Report

    Report Number
    3002808148-2023-09738
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Report Date
    November 14, 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
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DURING EVALUATION, THE FOLLOWING WERE FOUND; THE SCREEN DOES NOT POWER UP DUE TO A DEFECTIVE POWER SUPPLY (G1 BOARD). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED 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, AND TO CORRECT INFORMATION PROVIDED IN THE INITIAL REPORT. BASED ON THE RESULTS OF THE INVESTIGATION, THE CUSTOMER¿S ALLEGATION WAS CONFIRMED. IT WAS DETERMINED THAT THE PHENOMENON ¿DEVICE DOES NOT POWER ON (STARTUP)¿ OCCURRED DUE TO POWER UNIT FAILURE. THE CAUSE OF POWER UNIT FAILURE COULD NOT BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE REPLACEMENT OF THE G1 BOARD WAS REQUIRED TO RETURN THE INSTRUMENT TO THE OEM SPECIFICATION. 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 NO LONGER WORKS FAILURE SEARCH FOLLOWING A BLACK SCREEN. THE POWER SUPPLY BOARD DID NOT SUPPLY MORE THAN 24 VOLT TEST WITH 24 VOLT OLYMPUS BACKUP POWER SUPPLY SCREEN FUNCTIONAL. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446923 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown