BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTUS 4000E THYROID UPTAKE SYSTEM

    MDR report key: 18485762 · Received January 10, 2024

    Report

    Report Number
    2518443-2024-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 20, 2023
    Report Date
    January 10, 2024
    Manufacturer
    MIRION TECHNOLOGIES (CAPIINTEC), INC.
    Product Code
    IZD
    UDI-DI
    00859942006102
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SYSTEM WAS SHIPPED ON FEB. 5 2021, AND IS 3 YEARS OLD. PICTURES SENT BY END USER INDICATE THAT THE RETENTION PIN PLATE FAILED. END USER IS IN PROCESS OF RETURNING DEFECTIVE ASSEMBLY TO MANUFACTURER FOR ENGINEERING INVESTIGATION AND CONFIRMATION OF ROOT CAUSE. COMPONENT NOT YET RECEIVED AT TIME OF THIS REPORT.

    Description of Event or Problem · 0

    CAPTUS 4000E THYROID UPTAKE SYSTEM S/N (B)(6) WAS SHIPPED TO (B)(6) MEDICAL CENTER (NOW (B)(6)HEALTH) ON FEBRUARY 5, 2021. THE NUCLEAR MEDICINE TECHNICIAN WAS PERFORMING QUALITY ASSURANCE. THE COLLIMATOR UNEXPECTED DETACHED FROM THE SYSTEM ARM. PRIOR TO THIS EVENT, THE SYSTEM HAD BEEN FUNCTIONING PROPERLY. NO INJURY WAS REPORTED BY THE OPERATOR. 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
    1142206 CAPTUS 4000E THYROID UPTAKE SYSTEM THYROID UPTAKE SYSTEM IZD MIRION TECHNOLOGIES (CAPIINTEC), INC. 5430-30152 N/A 00859942006102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown