BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 13375389 · Received January 27, 2022

    Report

    Report Number
    8010047-2022-02105
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Date of Event
    December 27, 2021
    Report Date
    June 23, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170338496
    PMA / PMN Number
    K122831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. UPON EVALUATION OF THE DEVICE, FRONT PANEL LIGHT-EMITTING DIODE WAS CONTINUOUSLY GLOWING DUE TO FAULTY ZZ PRINTED CIRCUIT BOARD. IN ADDITION, FAULTY DR AND DP BOARD RESULTED IN AN E105 AND E300 COMMUNICATION ERRORS. LASTLY, HEAVY RUSTING ON THE COMPONENTS OF THE CM BOARD WAS OBSERVED. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME, HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE SUGGESTED PHENOMENON OF "E300 ERROR" AND "E105 OCCURS" WAS ESTIMATED TO HAVE OCCURRED DUE TO A "DP" CIRCUIT BOARD FAILURE. THE CAUSE OF THIS FAILURE COULD NOT BE FURTHER DETERMINED. THE SUGGESTED PHENOMENON OF "THE FRONT PANEL BLINKS" WAS ESTIMATED TO HAVE OCCURRED DUE TO A "ZZ" CIRCUIT BOARD FAILURE. THE CAUSE OF THIS FAILURE COULD NOT BE FURTHER DETERMINED. IT WAS DEEMED POSSIBLE THAT THAT THE OBSERVED RUST ON THE DP BOARD COULD HAVE BEEN PREVENTED VIA THE INSTRUCTIONS FOR USE (IFU): ·STORE THE EQUIPMENT IN THE LEVEL POSITION IN A CLEAN, DRY, AND STABLE LOCATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: E1 E2, E3, G2 (ADDED HEALTH PROFESSIONAL) AND G3 (THE AWARE DATE (G3) FOR THE INITIAL MDR FOR (MW 74278) IS 30DEC2022 AND NOT 03JAN2022 AS INITIALLY REPORTED). THIS SUPPLEMENTAL REPORT IS SUBMITTED TO PROVIDE ADDITIONAL INFORMATION AND APPLICABLE CORRECTIONS.

    Additional Manufacturer Narrative · 0

    SEE B5.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT THE VIDEO SYSTEM CENTER DISPLAY AN E-300 ERROR. THE EVENT OCCURRED DURING PREPARATION FOR USE. DURING A STANDARD SERVICE INSPECTION OF THE CUSTOMER RETURNED DEVICE, PRINTED CIRCUIT BOARD FAILURE WAS NOTED. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION FOUND AT INSPECTION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT: THE EVENT OCCURRED DURING THE GENERAL ROUTINE INSPECTION AND DOES NOT INVOLVE ANY PROCEDURE OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40156 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-170 04953170338496

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown