BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACQSIM

    MDR report key: 481461 · Received August 28, 2003

    Report

    Report Number
    1525965-2003-00010
    Event Type
    Malfunction
    Date Received
    August 28, 2003
    Date of Event
    July 31, 2003
    Report Date
    July 31, 2003
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    KPQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACQSIM-CT OPERATED WITH PREFERENCE OF AUTO SEND ON, TO SEND IMAGES TO VOXELQ. CUSTOMER IS ABLE TO OPEN STUDY BEFORE COMPLETE STUDY IS TRANSMITTED TO VOXEL. THE DR. MARKS TREATMENT ISOCENTER ON THE INCOMPLETE STUDY AND SAVE DATA. LATER, AFTER TRANSMISSION IS COMPLETE, THE PATIENT STUDY IS OPENED AND THE MARKET ISOCENTER HAS SHIFTED BY THE DISTANCE OF ADDITIONAL AREA COVERED BY COMPLETE SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACQSIM RADIATION THERAPY SIMULATION SYSTEM KPQ PHILIPS MEDICAL SYSTEMS ACQSIM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *