BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10501934 · Received September 8, 2020

    Report

    Report Number
    8010047-2020-06289
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 12, 2020
    Report Date
    December 23, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. THE CAUSE OF THE REPORTED PHENOMENON IS DETERMINED TO BE THAT AN UNSUPPORTED SIGNAL WAS APPLIED. IT WAS CONCLUDED THAT THIS EVENT WAS CAUSED BY HANDLING. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    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 ATTEMPTED TO PROVIDED TROUBLESHOOTING WITH THE USER OVER THE PHONE. THE TECHNICIAN ASKED THE USER TO CONFIRM THAT THE SDI CABLE WAS PLUGGED INTO AN OUTPUT ON THE CV-190. IT WAS PLUGGED IN. BOTH PORT A AND PORT B ON THE SDI 1 WAS IN USE. THERE WAS NO IMAGE. THE USER ADVISED THAT HE WAS RUNNING THE SDI CABLE FROM OUT OF 2 TO THE COMPUTER AND THEN ROUTING THE VIDEO BACK TO THE OEV-262H VIA HD15. THE USER WAS ABLE TO SEE THE COMPUTER IMAGE VIA THE HD15 INPUT ON THE MONITOR; HOWEVER, NEITHER PORT A SDI 1 IN NOR PORT B ARE SHOWING AN ENDOSCOPY IMAGE. WHEN THE CABLE WAS MOVED OVER TO SDI IN 2 ON THE MONITOR GAVE THE SAME RESULT. THE USER REPLIED BY EMAIL THAT IT APPEARS THE MONITOR WAS NOT RECEIVING THE INCOMING IMAGE FROM THE LENOVO COMPUTER. THE ISSUE WAS RESOLVED. THE IMAGE CAN NOW BE SEEN. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THERE WAS AN ISSUE WITH THE IMAGE. THE OEV 262H MONITOR HAS NO IMAGE. THERE WAS NO PATIENT INJURY OR HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968764 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1