BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTUS 4000E THYROID UPTAKE SYSTEM

    MDR report key: 18190383 · Received November 22, 2023

    Report

    Report Number
    2518443-2023-00004
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 27, 2023
    Report Date
    November 22, 2023
    Manufacturer
    MIRION TECHNOLOGIES (CAPINTEC), INC.
    Product Code
    IZD
    UDI-DI
    00859942006096
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ARM FAILURES UNDER ENGINEERING INVESTIGATION. ADDITIONAL CORRECTIVE ACTIONS PENDING.

    Description of Event or Problem · 0

    THYROID UPTAKE SYSTEM S/N (B)(6) WAS SHIPPED ON APRIL 19, 2018. THE TECHNICIAN WAS PERFORMING ROUTINE QC WHEN THE SYSTEM'S ARM UNEXPECTEDLY FELL TO ITS LOWEST POSITION. REVIEW BY ENGINEERING INDICATED A SPRING ARM FAILURE. NO INJURIES OCCURRED. 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
    1668579 CAPTUS 4000E THYROID UPTAKE SYSTEM THYROID UPTAKE SYSTEM IZD MIRION TECHNOLOGIES (CAPINTEC), INC. 5460-30141 N/A 00859942006096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown