BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 4100

    MDR report key: 2162071 · Received July 12, 2011

    Report

    Report Number
    9611343-2011-00053
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 12, 2011
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    MQB
    PMA / PMN Number
    K042053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, A PT FELL FROM THE TABLE OF AN INNOVA 4100 SYSTEM. THE PT WAS PLACED ON THE TABLE WITH THE AID OF A SLIDING BOARD WHICH REMAINED UNDER HIS BODY. THERE WAS A NURSE AND 2 TECHNICIANS PRESENT AT THE TABLE ON THE LEFT HAND SIDE. THE NURSE WAS SHAVING THE PT'S CHEST AND WAS APPLYING DISINFECTANT WHEN THE PT MOVED HIS ARMS ABOVE HIS HEAD. THE STAFF MEMBERS WERE ATTEMPTING TO MAKE HIM COMFORTABLE WHEN HE SUDDENLY JUMPED A LITTLE OR SLID OFF OF THE RIGHT HAND SIDE OF THE TABLE. THE PT EXPERIENCED A FRACTURED RIGHT ARM AND RIGHT HIP. THE PT ALSO HAD AN EXTERNAL BLEEDING HEAD INJURY IN 2 PLACES. A FOLLOW UP EXAM DISCOVERED A SMALL SUBDURAL HAEMATOMA HEAD INJURY. THE PT WAS TRANSPORTED TO AN INTENSIVE CARE UNIT (ICU). THE PT IS REPORTED TO BE RECOVERING AND IS NO LONGER IN AN ICU. THERE WAS NO ALLEGATION FROM THE SITE OF A DEVICE MALFUNCTION. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 4100 ANGIOGRAPHIC X-RAY SYSTEM MQB GE MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention