BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10711410 · Received October 21, 2020

    Report

    Report Number
    8010047-2020-07955
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 28, 2020
    Report Date
    December 18, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEGAL MANUFACTURER REVIEWED THE CONTENTS OF THIS COMPLAINT. THE LEGAL MANUFACTURER REPORTED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS ATTRIBUTED TO A SIGNAL FORMAT THAT CANNOT BE DISPLAYED HAS BEEN INPUT. IN ADDITION, IT WAS JUDGED THAT IT IS AN EVENT DUE TO HANDLING BECAUSE THERE WAS NO ABNORMALITY OF THE ACTUAL PRODUCT AND IT IS DESCRIBED IN THE INSTRUCTION MANUAL.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE USER¿S COMPLAINT WAS NOT CONFIRMED. THE TECHNICAL ASSISTANCE CENTER (TAC) TECHNICIAN TRIED TO TROUBLE SHOOT WITH SALESPERSON TO RESOLVE ISSUE. AFTER CHECKING THE OEV-261H MANUAL, THE DVI-SIGNAL WILL ONLY WORK FOR DVI-D TYPE SIGNAL. THE MANUAL WAS SENT TO THE USER FACILITY. THE STAFF WAS ABLE TO GET THE SIGNAL TO THE OEV-261H MONITOR WITHOUT ANY PROBLEM. IT IS POSSIBLE THAT THE SIGNAL WAS NOT IN THE DVI-D FORMAT AND IS NOW WORKING AFTER THE ADJUSTMENT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY NEEDED ASSISTANCE ON GETTING A STRYKER DVI SIGNAL TO THE OLYMPUS OEV-261H MONITOR. THE STRYKER IS UNABLE TO SHOW ANY COLOR BARS WITH THE DVI SIGNAL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178955 HIGH DEFINITION LCD MONITOR MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV261H

    Patients

    Seq Age Sex Outcome Treatment
    1