BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSPEED VCT

    MDR report key: 2081973 · Received April 5, 2011

    Report

    Report Number
    2126677-2011-00023
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 7, 2011
    Report Date
    April 5, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K040372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE UTILIZED FLOOR FASTENERS TO SECURE THE MOUNTING PLATE TO THE GANTRY. WHEN THE FASTENERS WERE REMOVED, THE MOUNTING PLATE WAS NO LONGER SUPPORTED AND FELL TO THE FLOOR BELOW. THE DE-INSTALL MANUAL STATES THAT BEFORE A DE-INSTALLATION BEGINS, THE DE-INSTALLER SHOULD REVIEW THE MANUALS USED FOR THE INSTALL OF THE SYSTEM FOR THE PURPOSE OF UNDERSTANDING DETAILS ABOUT THE INITIAL INSTALL. IN THIS CASE, THE INITIAL INSTALLATION METHOD WAS NOT VERIFIED PRIOR TO DE-INSTALLATION. GE HEALTHCARE DEFINES ONLY ONE METHOD TO SECURE THE MOUNTING SYSTEM, THROUGH USE OF BOLTS INTO A CONCRETE FLOOR. IT IS STATED THAT IF THE GE HEALTHCARE DEFINED METHOD IS NOT USED AS IN THIS CASE, RESPONSIBILITY FOR PROVIDING AN EQUIVALENT ANCHORING METHOD RESTS SOLELY WITH THE CUSTOMER'S CONTRACTOR OR STRUCTURAL ENGINEER. IN 2008, GE HEALTHCARE ADDED A REQUIREMENT THAT IF SUCH A DEVIATION WERE TO TAKE PLACE, A DOCUMENTED CONCESSION REVIEWED BY GE ENGINEERING IS REQUIRED. DE-INSTALLATION IS ALSO CONSIDERED IN THIS PROCESS. THIS SYSTEM WAS INSTALLED IN 2006, THEREFORE, THIS REQUIREMENT DID NOT EXIST AT THAT TIME. GE HEALTHCARE FIELD ENGINEERS ARE REQUIRED TO ATTEND INSTALLATION AND DE-INSTALLATION TRAINING WITH REGULAR REFRESHER TRAINING. SPECIFICS REGARDING THE DEVIATION PROCESS AND ALTERNATE INSTALLS WILL BE ADDED TO THE REGULAR CURRICULUM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DE-INSTALLATION OF A LIGHTSPEED VCT SYSTEM BY A GE HEALTHCARE FIELD SERVICE TEAM, A STEEL MOUNTING PLATE ATTACHED UNDER THE FLOOR BELOW THE GANTRY POSITION FELL FROM INSIDE THE CEILING THROUGH ACOUSTIC TILE INTO A POTENTIALLY OCCUPIED SPACE. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSPEED VCT COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK GE MEDICAL SYSTEMS, LLC 5124069

    Patients

    Seq Age Sex Outcome Treatment
    1