BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 12112155 · Received July 2, 2021

    Report

    Report Number
    8010047-2021-08365
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 25, 2021
    Report Date
    July 28, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSET UNIT WAS RETURNED (TO OAZ) FOR REPAIR / EVALUATION. THE EVALUATION CONFIRMED THE REPORTED NO POWER MALFUNCTION DUE TO A FAULTY POWER SUPPLY UNIT. THE POWER BOARD WAS REPLACED AND THE DEVICE FUNCTIONED AND TESTED APPROPRIATELY. 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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT WAS SUBMITTED TO PROVIDE A CORRECTION TO SECTION B5 PER ADDITIONAL INFORMATION FROM THE OLYMPUS (OAZ) SALES REPRESENTATIVE AND TO UPDATE THE FOLLOWING SECTIONS: G3, G6, H2 AND H10.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE ASSET HIGH DEFINITION LIQUID CRYSTAL DISPLAY MONITOR WAS FOUND TO HAVE A NO POWER MALFUNCTION DURING MAINTENANCE. NO PATIENT INVOLVEMENT OR PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE (OAZ) FURTHER REPORTED THE ASSET HIGH DEFINITION LIQUID CRYSTAL DISPLAY MONITOR REPORTEDLY WAS FOUND TO HAVE A NO POWER MALFUNCTION DURING A PROCEDURE. THE USER FACILITY USED AN ALTERNATIVE MONITOR THAT WAS EASILY ACCESSIBLE. NO PATIENT INJURY OR PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003382 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1