BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE

    MDR report key: 21279675 · Received January 30, 2025

    Report

    Report Number
    9610617-2025-00094
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Report Date
    June 25, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FET
    PMA / PMN Number
    K160044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COMPLAINT "NO IMAGE" WAS VERIFIED BY THE VIDEO REPAIR DEPARTMENT AT SEP. WHEN THE CAMERA CONTROL UNIT (TC201) IS POWERED ON, THE FAN RUNS AT FULL SPEED, BUT THE SCREEN REMAINS DARK WITH NO IMAGE DISPLAYED. DUE TO THE ABSENCE OF IMAGE OUTPUT, DEVICE INFORMATION SUCH AS SOFTWARE VERSION AND OPERATING HOURS COULD NOT BE RETRIEVED. A VISUAL INSPECTION OF THE TC201 HOUSING AND INTERNAL COMPONENTS REVEALED NO VISIBLE ABNORMALITIES. A FORMAL PRODUCT IMPROVEMENT PROJECT (KU40091) HAS BEEN LAUNCHED TO RESOLVE THE ISSUE AND MITIGATE RECURRENCE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS NO IMAGE. THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165935 CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE FET KARL STORZ SE & CO. KG TC201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown