BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRANET COLLIMATOR

    MDR report key: 899980 · Received August 21, 2007

    Report

    Report Number
    2126677-2007-00026
    Event Type
    Malfunction
    Date Received
    August 21, 2007
    Date of Event
    October 13, 2005
    Report Date
    October 13, 2005
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KPR
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS X-RAY SYSTEM WAS INSTALLED IN 1982. AT THE TIME OF THE INCIDENT, THE COLLIMATOR WAS REPLACED. SYSTEM DATES BACK PRIOR TO GE MERGER/ACQUISITION. GE IS VERIFYING 510K NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLIMATOR DETACHED AND FELL. NO INJURY WAS REPORTED. A SERIOUS INJURY COULD RESULT IF THE COLLIMATOR WERE TO CONTACT THE PT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRANET COLLIMATOR KPR GE MEDICAL SYSTEMS, LLC 45296017 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR