BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 11293876 · Received February 8, 2021

    Report

    Report Number
    8010047-2021-02376
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 12, 2021
    Report Date
    April 6, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, THIS IS NOT A REPORTABLE MALFUNCTION. PER THE LEGAL MANUFACTURER THERE IS NO POTENTIAL FOR THIS ISSUE TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS EVALUATED IN THE FIELD BY A FIELD SERVICE ENGINEER (FSE). THE DEFINITIVE CAUSE OF THE CUSTOMER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. PHYSICAL EVALUATION OF THE COMPLAINT DEVICE REVEALS: THE SERIAL DIGITAL INTERFACE (SDI) IN PORT 1 DOES NOT WORK. A SDI CABLE WAS CONNECTED FROM SDI OUT IN THE CV-190 TO SDI IN PORT 1 IN THE OEV-262H AND NO IMAGE WAS DISPLAYED WITH SDI PORT 1 SELECTED IN THE INPUT SELECTION MENU. ALSO UNABLE TO GET THE IMAGE TO APPEAR ON ANOTHER MONITOR WITH THE SIGNAL RUN THROUGH THE OEV-262H. WHEN THE SDI CABLE WAS CONNECTED TO SDI IN PORT 2 IN THE OEV-262H AND THE INPUT SELECTION WAS CHANGED TO SDI PORT 2, THE IMAGE DISPLAYED. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT REPORTED WHILE SETTING UP A HIGH DEFINITION LCD MONITOR OUT OF THE BOX, THE SERIAL DIGITAL INTERFACE (SDI) IN NUMBER ONE PORT DID NOT WORK WHEN AN SDI CABLE WAS CONNECTED, NO IMAGE WAS DISPLAYED. THERE WAS NO PATIENT CONTACT/IMPACT RELATED TO THIS OCCURRENCE. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190192 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1