BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 11393501 · Received March 1, 2021

    Report

    Report Number
    8010047-2021-03134
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    February 4, 2021
    Report Date
    April 2, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. ALL RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS CONFIRMED THAT THE IMAGES WILL BE DISPLAYED BY INPUTTING SIGNALS FROM THE PROCESSOR DIRECTLY INTO THE MONITOR, IT WAS PRESUMED THAT THE REPORTED PHENOMENON WAS CAUSED BY OTHER FACTORS OTHER THAN THE DEVICE (CONNECTING CABLES). OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    TAC (TECHNICAL ASSISTANCE CENTER) SUPPORT ENGINEER DURING A CALL, HAD THE CUSTOMER DISCONNECT THE SDI CABLE FROM THEIR BROKEN MONITOR AND CONNECTED THE OEV-262H DIRECTLY TO THE CV-190 VIA SDI (SERIAL DIGITAL INTERFACE) OUT 2 ON THE CV-190 TO SDI IN 1 ON THE OEV-262H. TAC HAD THEM CHANGE THE INPUT ON THEIR OEV-262H PORT (B) TO SDI 1 IN. ONCE COMPLETED, THE CUSTOMER WAS ABLE TO GET A CLEAR IMAGE. THE ISSUE WAS RESOLVED , NO FURTHER ISSUES WERE REPORTED. BASED ON TROUBLESHOOTING CONDUCTED BY TAC, THE ISSUE COULD BE DUE TO USE HANDLING . IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE OEV-262H WAS NO IMAGE VIA A UWIT (WIRELESS IMAGE TRANSMITTER UNIT). THERE WAS NO PATIENT INVOLVEMENT. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290526 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1