BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICKER 2000

    MDR report key: 3072597 · Received March 19, 2013

    Report

    Report Number
    3072597
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 19, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    SCAN WAS NOT SAVED BY COMPUTER. ALL IMAGES WERE NOT STORED BY THE COMPUTER. PATIENT HAD TO HAVE ADDITIONAL SCANNING DONE. NO ADDITIONAL CONTRAST WAS USED - EXAM COMPLETED AND REPORTED BY RADIOLOGIST - CLINICAL ENGINEERING WAS NOTIFIED OF INCIDENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SCAN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114852 PICKER 2000 CT SCANNER JAK PHILIPS MEDICAL SYSTEMS 2000 3409

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR