BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTUS 3000

    MDR report key: 5398253 · Received January 29, 2016

    Report

    Report Number
    2518443-2016-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2016
    Manufacturer
    CAPINTEC, INC.
    Product Code
    IZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPINTEC HAS CONTRACTED WITH TWO OUTSIDE FIRMS, HAMEL ENGINEERING SCIENCES, INC. AND INDUSTRIAL TESTING LABORATORY SERVICES, LLC , FOR STATIC, DYNAMIC AND METALLURGICAL STUDIES. TO DATE, THE REPORTS HAVE BEEN INCONCLUSIVE IN DETERMINING ROOT CAUSE. ADDITIONAL TESTING IS IN PROCESS.

    Description of Event or Problem · 1

    WHILE PERFORMING ROUTINE QUALITY ASSURANCE TESTING ON THE CAPINTE CAPTUS 3000 THYROID UPTAKE SYSTEM, A COMPONENT IN THE SPRING ARM (TENSION ROD) BROKE CAUSING THE ARM WITH THE COLLIMATOR TO FALL DOWNWARD TO ITS LOWEST POINT OF TRAVEL, WHICH IS APPROXIMATELY 25 INCHES FROM THE GROUND. THE COLLIMATOR AND ARM WEIGH 45 POUNDS, AND COULD CAUSE AN INJURY IF IT HITS A PATIENT OR OPERATOR. IN THIS CASE, NO PATIENT WAS INVOLVED, AND NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58554 CAPTUS 3000 THYROID UPTAKE SYSTEM IZD CAPINTEC, INC. CAPTUS 3000 NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1