BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 12245546 · Received July 29, 2021

    Report

    Report Number
    8010047-2021-09517
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    July 6, 2021
    Report Date
    August 19, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE OF NO IMAGE FOR THE DEVICE WAS RESOLVED WITH TROUBLE SHOOTING AND SELECTION OF THE CORRECT SELECTION OF THE SERIAL DIGITAL INTERFACE (SDI) 2 IN THE FRONT MENU, AS THE SDI 2 PORT WAS BEING USED AT THE BACK OF THE DEVICE. THE DEVICE IS NOT RETURNED AS THERE WAS NO FAILURE OF THE DEVICE. AN EVALUATION IS BEING PERFORMED BASED ON HISTORICAL RECORDS AND COMMUNICATION. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT DEVICE HAS NO ABNORMALITY IN MANUFACTURING, SPECIAL ADOPTION, OR UNEVENNESS. THERE IS NO HISTORY OF REPAIR FOR THIS DEVICE WITHIN ONE YEAR. THE CAUSE OF THIS ISSUE IS DUE TO HANDLING AS THE INSTRUCTION MANUAL GIVES DIRECTION FOR WHAT TO DO WHEN THERE IS NO IMAGE. THE INSTRUCTIONS FOR USE FOR OPERATION MANUAL INCLUDES THE FOLLOWING STATEMENTS: 6.1 HOW TO DISTINGUISH AND COPE WITH ANOMALIES ABNORMAL CONTENT: IMAGES DO NOT APPEAR. CAUSE: THE INPUT SIGNAL SELECTION BUTTON IS NOT SET PROPERLY. CORRECTIVE METHOD: CHOOSE AN APPROPRIATE INPUT TERMINAL WITH THE INPUT SELECTION BUTTON ON THE FRONT PANEL. 6.1 TROUBLESHOOTING GUIDE MALFUNCTION: NO IMAGE. CAUSE: THE BUTTON FOR SWITCHING INPUT SIGNALS HAS BEEN INCORRECTLY SET. REMEDY: USE THE INPUT BUTTON ON THE FRONT PANEL TO SELECT AN APPROPRIATE TERMINAL.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED AS THE ISSUE WAS RESOLVED WITH TROUBLESHOOTING AND THE CORRECT SELECTION OF SDI 2 IN THE MENU TO MATCH THE PORT BEING USED. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED WHEN ANY RELEVANT NEW INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED FOR THIS EVENT, DURING SET UP WHEN THE SCOPE WAS PLUGGED IN, THE DEVICE WOULD NOT SHOW AN IMAGE. THE ISSUE WAS RESOLVED UPON TROUBLESHOOTING BY THE CORRECT SELECTION OF THE SERIAL DIGITAL INTERFACE (SDI) 2 IN THE FRONT MENU, AS THE SDI 2 PORT WAS BEING USED AT THE BACK OF THE DEVICE. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145904 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1