BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 2000

    MDR report key: 2586722 · Received May 22, 2012

    Report

    Report Number
    9611343-2012-00018
    Event Type
    Injury
    Date Received
    May 22, 2012
    Date of Event
    April 27, 2012
    Report Date
    May 3, 2012
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    JAA
    PMA / PMN Number
    K993037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHILE POSITIONING THE GANTRY, THE GANTRY STRUCK THE SURGICAL LAMP RM AND BROKE THE CASTING ALLOWING IT TO FALL. A NURSE WAS STRUCK IN THE SIDE OF THE HEAD BY THE ARM OF THE LAMP. THE NURSE WHO WAS STRUCK SUFFERED A CLOSED HEAD INJURY, CONCUSSION, HEMATOMA DOWN TO THE NECK AND WAS SEEN IN THE EMERGENCY ROOM. THE NURSE WAS OFF OF WORK FOR TWO WEEKS AND TOOK OVER THE COUNTER MEDICATION FOR HEADACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2000 FLUOROSCOPIC X-RAY SYSTEM JAA GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other