BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM VH GANTRY

    MDR report key: 538211 · Received March 23, 2004

    Report

    Report Number
    9613299-2004-00003
    Event Type
    Malfunction
    Date Received
    March 23, 2004
    Date of Event
    March 2, 2004
    Report Date
    March 23, 2004
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED CONCERNING COLLIMATOR FALL BETWEEN DETECTOR HEADS DURING COLLIMATOR EXCHANGE PROCESS. THE OPERATOR WAS DRIVING THE COLLIMATOR CART WITH VP6 COLLIMATOR MOUNTED ON INTO THE GANTRY TO BE INSTALLED. THE INCIDENT OCCURRED DURING THE PROCESS OF COLLIMATOR EXCHANGE. DURING THE COLLIMATOR EXCHANGE PROCESS PT IS NOT PRESENTED AT THE DETECTOR AREA AND THE OPERATOR IS STANDING AT THE BACK SIDE OF THE CART WHILE THE COLLIMATOR IS LOADED FROM THE OPPOSITE SIDE. SYSTEM WAS DAMAGED AT THE DETECTOR AREA BUT NO ONE WAS INJURED AND NO OTHER ADVERSE EFFECTS HAD BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM VH GANTRY NUCLEAR MEDICINE KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING ASM001092 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA