BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTILIX 1600XX

    MDR report key: 1737875 · Received June 11, 2010

    Report

    Report Number
    9611343-2010-00008
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    March 8, 2010
    Report Date
    March 8, 2010
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    LLZ
    PMA / PMN Number
    K924310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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 LLZ GE MEDICAL SYSTEMS SCS 12085A

    Patients

    Seq Age Sex Outcome Treatment
    1