BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEGACY TABLE

    MDR report key: 2034760 · Received March 24, 2011

    Report

    Report Number
    2126677-2011-00021
    Event Type
    Other
    Date Received
    March 24, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 24, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IXR
    PMA / PMN Number
    K760466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING A FLUOROSCOPY EXAM, THE USER ANGULATED THE FLUOROGRAPHIC TABLE CAUSING THE TOWER TO COLLIDE WITH THE OVER HEAD TUBE SUPPORT. THE COLLISION CAUSED THE CAMERA TO BE DISLODGED FROM ITS MOUNT AND IT FELL APPROX TWO FEET. IT WAS PREVENTED FROM FALLING TO THE FLOOR BY ITS CONNECTED CABLING. THE USER HALTED THE EXAM AND MOVED THE PT TO ANOTHER ROOM. THERE WAS NO REPORTED INJURY. 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 LEGACY TABLE FLUOROSCOPIC TILTING TABLE IXR GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1