BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTUS 3000 THYROID UPTAKE SYSTEM

    MDR report key: 8154548 · Received December 12, 2018

    Report

    Report Number
    2518443-2018-00002
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 13, 2018
    Report Date
    December 12, 2018
    Manufacturer
    CAPINTEC, INC.
    Product Code
    IZD
    PMA / PMN Number
    CLASS I,EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 CAPINTEC WAS INFORMED OF AN ARM FAILURE ON A CAPTUS 3000 THYROID UPDATE SYSTEM- SERIAL NUMBER (B)(4). A COMPONENT IN THE SPRING ARM (TENSION ROD) BROKE CAUSING THE ARM WITH THE COLLIMATOR TO FALL DOWNWARD. NO STAFF OR PATIENT WAS IN THE ROOM AT THE TIME OF THE EVENT. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997570 CAPTUS 3000 THYROID UPTAKE SYSTEM THYROID UPTAKE SYSTEM IZD CAPINTEC, INC. 5430-0077

    Patients

    Seq Age Sex Outcome Treatment
    1