BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTILIX 1600XX

    MDR report key: 2460846 · Received February 13, 2012

    Report

    Report Number
    2126677-2012-00021
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    March 8, 2010
    Report Date
    March 8, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KXJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THIS EVENT WAS ORIGINALLY REPORTED ON 06/11/2010 UNDER MDR 9611343-2010-00008. THE MFG SITE LOCATION IS BEING CORRECTED FROM GE MEDICAL SYSTEMS (B)(4) TO GE MEDICAL SYSTEMS, LLC (B)(4). THIS REPORT (MDR 2126677-2012-00021) REPLACES MDR 9611343-2010-00008. VISUAL INSPECTION BY A GE FIELD ENGINEER (FE) REVEALED THAT THE DETACHMENT WAS DUE TO LOOSE SCREWS. THE FE ALSO INDICATED THAT ROUGH HANDLING OF THE EQUIPMENT BY THE OPERATORS MAY HAVE CONTRIBUTED TO THE EVENT. THE FE FIXED THE PROBLEM BY REPLACING THE COLLIMATOR. THE INVESTIGATION REVEALED THAT THE ROOT CAUSE OF THE COLLIMATOR'S DETACHMENT FROM TUBE ASSEMBLY WAS DUE TO INADEQUATE APPLICATION OF TORQUE ON THE SCREWS RETAINING THE COLLIMATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLIMATOR DETACHED FROM THE TUBE SUSPENSION OF AN X-RAY SYSTEM. THERE WAS NO PT INVOLVEMENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTILIX 1600XX KXJ GE MEDICAL SYSTEMS, LLC 12085A

    Patients

    Seq Age Sex Outcome Treatment
    1