BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIGHTSPEED CT

    MDR report key: 3763406 · Received April 11, 2014

    Report

    Report Number
    9613445-2014-00101
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    JAK
    PMA / PMN Number
    K082816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICING OF THE BRIGHTSPEED CT SYSTEM, A GE EMPLOYEE REMOVED THE GANTRY COVERS. WHEN PUTTING THE FRONT COVER BACK ON, THE EMPLOYEE FELT RESISTANCE. THE EMPLOYEE PUSHED HARDER AND PINCHED THEIR 5TH DIGIT (FINGER) IN BETWEEN THE COVER AND THE CT GANTRY. IN THE EMERGENCY ROOM, A HAND SURGEON REMOVED THE FINGERNAIL, "STRAIGHTENED" THE BROKEN DISTAL PHALANGE AND APPLIED A SPLINT AND BANDAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220912 BRIGHTSPEED CT COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK GE HANGWEI MEDICAL SYSTEMS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other