BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPOWER CT INJECTOR SYSTEMS - MOUNTING ARM ACC.

    MDR report key: 1516931 · Received October 16, 2009

    Report

    Report Number
    2134243-2009-00012
    Event Type
    Malfunction
    Date Received
    October 16, 2009
    Date of Event
    September 17, 2009
    Report Date
    October 16, 2009
    Manufacturer
    ACIST MEDICAL SYSTEMS
    Product Code
    DXT
    PMA / PMN Number
    K063029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTICULATING ARM AND J-ARM WERE RETURNED TO ACIST ON SEPTEMBER 25, 2009. INVESTIGATION DETERMINED THAT AS THE EMPOWER CT INJECTOR OR THE LOWER END OF THE J-ARM WERE MANUALLY MOVED DURING NORMAL AND ACCEPTABLE USAGE, THE JOINT HOLDING THE CONNECTING INSERT TO THE J-ARM TUBING BECAME LOOSE. THIS CAUSED THE J-ARM AND INJECTOR HEAD TO FALL. WHEN THIS OCCURRED, THE TECHNICIAN CAUGHT THE INJECTOR HEAD AND J-ARM ASSEMBLY. THE TECHNICIAN EXPERIENCED MUSCLE SPASMS IMMEDIATELY AFTER THE EVENT BUT EXPERIENCED NO SYMPTOMS THE FOLLOWING DAY. THERE IS NO REPORT OF THE TECHNICIAN SEEKING MEDICAL CARE AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: INJECTOR HEAD DETACHED FROM UNIT (EMPOWER CT INJECTOR SYSTEM). BOTH THE ARTICULATING ARM AND J-ARM BROKE AND FELL ON AN EMPLOYEE WHO WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPOWER CT INJECTOR SYSTEMS - MOUNTING ARM ACC. CT INJECTOR DXT ACIST MEDICAL SYSTEMS 9988R

    Patients

    Seq Age Sex Outcome Treatment
    1