BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTX E XR

    MDR report key: 1429507 · Received April 9, 2009

    Report

    Report Number
    2126677-2009-00027
    Event Type
    Malfunction
    Date Received
    April 9, 2009
    Date of Event
    February 20, 2009
    Report Date
    March 12, 2009
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IXR
    PMA / PMN Number
    K760466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FRONT TRANSLATION CHAIN BROKE DURING ANGULATION AFER THE TABLE WAS DRIVEN INTO THE CEILING MONITOR SUSPENSION. NO INJURY WAS REPORTED. A PT WAS ON THE TABLE BUT WAS NOT INJURED. IF THE EVENT WERE TO RECUR, THE CONCERN IS THAT A SERIOUS INJURY MAY RESULT IF THE OPERATOR HAD THEIR FOOT UNDER THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTX E XR IXR GE MEDICAL SYSTEMS, LLC 46-26-2751G4

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR