BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CAPTUS 4000E THYROID UPTAKE SYSTEM

    MDR report key: 17539463 · Received August 14, 2023

    Report

    Report Number
    2518443-2023-00002
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    June 24, 2023
    Report Date
    August 11, 2023
    Manufacturer
    MIRION TECHNOLOGIES (CAPINTEC), INC.
    Product Code
    IZD
    UDI-DI
    00859942006096
    PMA / PMN Number
    CLASS I
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CAPTUS 4000E THYROID UPTAKE SYSTEM S/N (B)(6) WAS SHIPPED TO RAPP-ISO GMBH, GERMANY IN AUGUST 2020. ON JUNE 24, 2023 THE TECHNICIAN ATTEMPTED TO OPERATE THE CAPTUS 4000E TO MEASURE A PHANTOM. THE PROBE UNEXPECTEDLY DISLODGED FROM THE CARRIAGE ARM. THE ARM'S ARTICULATION HAD BECOME LOOSE AND EVENTUALLY DETACHED. PRIOR TO THIS EVENT, THE SYSTEM HAD BEEN FUNCTIONING PROPERLY. USER REPORTED NO INJURY. THE COLLIMATOR ASSEMBLY WEIGHS 28 POUNDS, AND THERE IS THE POTENTIAL FOR SERIOUS INJURY IF THE COLLIMATOR WERE TO FALL AND COME INTO CONTACT WITH A PATIENT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050005 CAPTUS 4000E THYROID UPTAKE SYSTEM THYROID UPTAKE SYSTEM IZD MIRION TECHNOLOGIES (CAPINTEC), INC. 5130-30151 N/A 00859942006096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown