BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRANET S

    MDR report key: 857438 · Received May 30, 2007

    Report

    Report Number
    9611343-2007-00043
    Event Type
    Malfunction
    Date Received
    May 30, 2007
    Date of Event
    April 15, 2007
    Report Date
    May 30, 2007
    Manufacturer
    GE MEDICAL SYSTEMS S.C.S.
    Product Code
    IZW
    PMA / PMN Number
    K894142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE EVENT WAS THREE OF THE SIX SCREWS USED TO HOLD THE COLLIMATOR WERE MISSING. THERE IS DOCUMENTATION IN THE SERVICE MANUAL INSTRUCTING THE PERIODIC CHECKING OF THE FASTENERS HOLDING THE COLLIMATOR. ATTEMPTS WERE MADE TO GET THE PATIENT INFORMATION, THEY WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLIMATOR FELL FROM THE X-RAY ASSEMBLY AND WAS CAUGHT BY THE XR TECHNOLOGIST WHO REPORTED A SPRAINED HAND. THE CONCERN IS THAT IF THE EVENT WERE TO RECUR, SERIOUS INJURY MAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRANET S IZW GE MEDICAL SYSTEMS S.C.S. 2204643 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR