BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTUS 4000E THYROID UPTAKE SYSTEM

    MDR report key: 17539457 · Received August 14, 2023

    Report

    Report Number
    2518443-2023-00001
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 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
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THYROID UPTAKE SYSTEM S/N (B)(6) WAS SHIPPED ON APRIL 2016. THE TECHNICIAN WAS PERFORMING ROUTINE CALIBRATION WHEN THE SPRING ARM FELL AND HIT THE TECHNICIAN'S LEG, CAUSING A BRUISE. NO MEDICAL TREATMENT WAS REQUIRED. DISCUSSION WITH USER INDICATES THAT THE TECHNICIAN ROUTINELY MOVED THE ARM UP AND DOWN WITHOUT RELEASING THE LOCKING MECHANISM. A REPLACEMENT ASSEMBLY WAS SHIPPED AND USER INSTRUCTED TO RETURN THE DEFECTIVE PART TO MANUFACTURER FOR ENGINEERING EVALUATION AND IDENTIFICATION OF ROOT CAUSE. THE COLLIMATOR AND ARM WEIGH AND SPRING ARM ASSEMBLY WEIGH 45 POUNDS, WHICH HAS THE POTENTIAL FOR SERIOUS INJURY TO EITHER PATIENT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085061 CAPTUS 4000E THYROID UPTAKE SYSTEM THYROID UPTAKE SYSTEM IZD MIRION TECHNOLOGIES (CAPINTEC), INC. 5430-30151 N/A 00859942006096

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other