BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTUS 4000E

    MDR report key: 9166032 · Received October 8, 2019

    Report

    Report Number
    2518443-2019-00002
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 19, 2019
    Report Date
    October 8, 2019
    Manufacturer
    MIRION TECHNOLOGIES (CAPINTEC), INC.
    Product Code
    IZD
    UDI-DI
    00859942006102
    PMA / PMN Number
    CLASS I
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON 9/19/19 END USER CONTACTED CAPINTEC TO REPORT THAT THE COLLIMATOR FELL OFF A CAPTUS 4000E SYSTEM, S/N (B)(4). USER WAS PERFORMING QC ON THE SYSTEM, AND FOUND THE COLLIMATOR DIFFICULT TO TURN. CONTINUING TO MOVE THE COLLIMATOR CAUSED IT TO FALL OFF THE ARM. THE FALL WAS BROKEN BY THE CABLE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959479 CAPTUS 4000E THYROID UPTAKE SYSTEM IZD MIRION TECHNOLOGIES (CAPINTEC), INC. 5430-301542 NA 00859942006102

    Patients

    Seq Age Sex Outcome Treatment
    1