BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLI-C

    MDR report key: 16452169 · Received February 28, 2023

    Report

    Report Number
    1000188474-2023-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    January 31, 2023
    Report Date
    February 28, 2023
    Manufacturer
    NRT X-RAY A/S
    Product Code
    OWB
    UDI-DI
    05713464000121
    PMA / PMN Number
    K173631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FROM PHOTOS RECEIVED FROM SITE, WE CAN CLEARLY SEE THAT THE DRIVE SHAFT IS BROKEN. A NEW DRIVE SHAFT HAS BEEN INSTALLED ON SITE, AND THE PARTS INVOLVED IN THE EVENT ARE BEING TRANSPORTED TO NRT FOR INVESTIGATION. ONCE RECEIVED, THE PARTS WILL UNDERGO METALLURGIC ANALYSIS TO ESTABLISH THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    DURING AN EXAMINATION OF A PATIENT, IT WAS FOUND THAT A DRIVE SHAFT IN THE IDE MOVEMENT OF THE INTELLI-C X-RAY DEVICE HAD BROKEN. THE IDE MOVEMENT THAT DRIVES THE DETECTOR INTO POSITION, MOVED UNTIL IT WAS STOPPED BY THE MOVEMENT END STOP. THE EVENT DID NOT CAUSE ANY INJURY TO PATIENT OR OPERATOR AS NO ONE WAS HIT BY THE UNINTENDED MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658205 INTELLI-C INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB NRT X-RAY A/S 03400010 05713464000121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown