BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 11620667 · Received April 6, 2021

    Report

    Report Number
    8010047-2021-04663
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 12, 2021
    Report Date
    May 7, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION AND TO CORRECT INFORMATION PROVIDED ON THE INITIAL REPORT. 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 LEGAL MANUFACTURER'S INVESTIGATION, THE PHENOMENA (FAULTY CIRCUIT BOARDS) WAS LIKELY CAUSED BY ACCIDENTAL FAILURE.

    Additional Manufacturer Narrative · 1

    THE REFERENCED DEVICE WAS RETURNED TO THE OLYMPUS SERVICE CENTER. THE EVALUATION CONFIRMED THE REPORTED OF NOT POWERING ON WAS DUE TO A FAULTY BOARD (G1) . IN ADDITION, THERE IS NO SERIAL DIGITAL INTERFACE, SDI-1, INPUT SIGNAL IMAGE DUE TO A FAULTY BOARD (QB). A REVIEW OF THE DEVICE'S REPAIR HISTORY SHOWS NO PREVIOUS REPAIR RECORDS; THE DEVICE WAS PURCHASED ON (B)(6) 2019. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED MALFUNCTION CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED EVENT, THE HIGH DEFINITION LIQUID CRYSTAL DISPLAY MONITOR REPORTEDLY WAS NOT POWER ON, NO POWER. THE USER TRIED SEVERAL SOURCES TO POWER THE MONITOR BUT IT WOULD NOT TURN ON. NO PATIENT INJURY OR HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517310 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1