BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RALCO COLLIMATOR IN XPLORER 1590 SYSTEM

    MDR report key: 792372 · Received November 27, 2006

    Report

    Report Number
    9616853-2006-00003
    Event Type
    Malfunction
    Date Received
    November 27, 2006
    Date of Event
    July 20, 2006
    Report Date
    November 24, 2006
    Manufacturer
    RALCO INC
    Product Code
    IZW
    PMA / PMN Number
    K946320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RALCO R392 COLLIMATOR WAS RETURNED TO IMAGING DYNAMICS FOR INITIAL EVALUATION. IMAGING DYNAMICS DETERMINED THAT THIS WAS AN ISOLATED INSTALLATION ERROR AND NOT A MALFUNCTION OF THE DEVICE. THE COLLIMATOR WAS REPLACED WITH A DIFFERENT COLLIMATOR AS PER CUSTOMER'S REQUEST. THE ERROR WITH THE INSTALLATION WAS COMMUNICATED TO THE IMAGING DYNAMIC'S DEALER FOR THEIR CORRECTIVE / PREVENTIVE ACTION. THERE WAS NO REQUIREMENT TO INFORM THE MANUFACTURER SINCE THE PRODUCT MANUAL HAS VERY CLEAR INSTRUCTIONS ON INSTALLATION. IMAGING DYNAMICS INITIALLY DETERMINED THAT THIS IS NOT A REPORTABLE EVENT DUE TO THE ISOLATED NATURE OF THE INCIDENT AS WELL AS THE FACT THAT IT WAS A FAULTY INSTALLATION BY THE DEALER. THE HOSPITAL INDICATED THAT THEY HAVE SUBMITTED A MDR REPORT TO FDA ON THIS INCIDENT. HOWEVER, IMAGING DYNAMICS COULD NOT VERIFY THEIR SUBMISSION AND DECIDED TO SEND THIS REPORT AFTER DISCUSSION WITH FDA INSPECTOR WHO INSPECTED IMAGING DYNAMICS IN 2006.

    Description of Event or Problem · 1

    A COLLIMATOR ATTACHED TO A CEILING MOUNTED X-RAY TUBE ASSEMBLY CAME LOOSE WHILE ADJUSTING BY THE TECHNOLOGIST. THE TECHNOLOGIST CAUGHT THE UNIT BEFORE IT FELL ON TO THE TABLE. NO PATIENT INVOLVED IN THE INCIDENT. THE RALCO R 302 COLLIMATOR WAS ATTACHED TO THE CEILING MOUNTED TUBE ASSEMBLY AS AN INTEGRATED COMPONENT OF THE XPLORER 1590 SYSTEM. IMAGING DYNAMICS INITIALLY DETERMINED THAT THIS IS NOT A REPORTABLE EVENT DUE TO THE ISOLATED NATURE OF THE INCIDENT AS WELL AS THE FACT THAT IT WAS A FAULTY INSTALLATION BY THE DEALER. THE HOSPITAL INDICATED THAT THEY HAVE SUBMITTED A MDR REPORT TO FDA ON THIS INCIDENT. HOWEVER, IMAGING DYNAMICS COULD NOT VERIFY THEIR SUBMISSION AND DECIDED TO SEND THIS REPORT AFTER DISCUSSION WITH FDA INSPECTOR WHO INSPECTED IMAGING DYNAMICS IN 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RALCO COLLIMATOR IN XPLORER 1590 SYSTEM COLLIMATOR IZW RALCO INC R 302 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *