BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTUS 4000

    MDR report key: 8384799 · Received March 2, 2019

    Report

    Report Number
    2518443-2019-00001
    Event Type
    Malfunction
    Date Received
    March 2, 2019
    Date of Event
    February 4, 2019
    Report Date
    March 2, 2019
    Manufacturer
    CAPINTEC, INC.
    Product Code
    IZD
    UDI-DI
    00859942006102
    PMA / PMN Number
    N/A CLASS I
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019 CAPINTEC WAS INFORMED THAT THE COLLIMATOR FELL OFF A CAPTUS 4000 THYROID UPDATE SYSTEM- SERIAL NUMBER (B)(4). TECHNOLOGIST JUST COMPLETED QC ON THE SYSTEM. SHE WAS PERFORMING CAPSULE COUNTS WHEN THE COLLIMATOR FELL OFF. NO INJURIES OCCURRED. SERVICE PERSONNEL REPLACED THE COLLIMATOR ASSEMBLY ON SITE. USER WAS INSTRUCTED TO RETURN FAILED PARTS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178053 CAPTUS 4000 THYROID UPTAKE SYSTEM IZD CAPINTEC, INC. CAPTUS 4000E N/A 00859942006102

    Patients

    Seq Age Sex Outcome Treatment
    1