BEUDAMED
    FDA Adverse Event Summary report: N

    CT SECURA MANUFACTURED FEB 2001

    MDR report key: 413395 · Received August 26, 2002

    Report

    Report Number
    MW1025978
    Date Received
    August 26, 2002
    Date of Event
    April 18, 2002
    Report Date
    August 13, 2002
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    JAK
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    MACHINE TRANSFERRING ACQUIRED IMAGES INTO WRONG PT'S FILE IN IMAGE HANDLER. HAVING TO REBOOT THE MACHINE DAILY/TO EVERY OTHER DAY TO GET MACHINE TO PROPERLY WORK. IMAGE HANDLER FREEZING, NOT ALLOWING MOUSE FUNCTION OR CONTINUATION OF SCAN. TURNING MACHINE ON AND OFF, IS WHAT SVC WOULD TELL RPTR TO DO. TO THIS DATE, PHILIPS HAS OFFERED NO EXPLANATION FOR IMAGE PROBLEM. STUDIES ARE COPIED ON A DISC FOR EVALUATION. MACHINE HAS BEEN A PROBLEM FROM DAY 1. RPTR DOES HAVE DOCUMENTATION OF EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT SECURA MANUFACTURED FEB 2001 COMPUTED TOMOGRAPHY (CT) MACHINE JAK PHILIPS MEDICAL SYSTEMS PHILIPS CT SECURA *
    2 CT SECURA MANUFACTURED FEB 2001 COMPUTED TOMOGRAPHY (CT) MACHINE JAK PHILIPS MEDICAL SYSTEMS PHILIPS CT SECURA *

    Patients

    Seq Age Sex Outcome Treatment
    1 *