BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRANET COLLIMATOR

    MDR report key: 122943 · Received September 26, 1997

    Report

    Report Number
    57331-1997-00032
    Event Type
    Malfunction
    Date Received
    September 26, 1997
    Date of Event
    August 12, 1997
    Report Date
    September 26, 1997
    Manufacturer
    GENERAL ELECTRIC CO.
    Product Code
    KPW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT THE COLLIMATOR DETACHED FROM ITS MOUNT AND FELL. APPARENTLY, THE MOUNTING SCREWS BACKED OUT ALLOWING IT TO FALL. THE SCREWS WERE REPLACED AND SECURED AND THE UNIT PLACED BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRANET COLLIMATOR DIAGNOSTIC X-RAY KPW GENERAL ELECTRIC CO. 45296017 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *