BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACQPLAN 5.0

    MDR report key: 481485 · Received August 28, 2003

    Report

    Report Number
    1525965-2003-00009
    Event Type
    Malfunction
    Date Received
    August 28, 2003
    Date of Event
    August 1, 2003
    Report Date
    August 1, 2003
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LHN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INCIDENT INVOLVED RADIATION DOSE PLANNING, AN ERROR IN CALCULATION OCCURRED. BECAUSE THE ERROR WAS QUITE OBVIOUS THE TREATMENT WAS NOT DELIVERED AS PLANNED. AN ORIGINAL PLAN WAS DONE AND CALCULATED CORRECTLY, AN OPTION TO COPY THE PLAN WAS UTILIZED, AND THE AREA OF CALCULATION WAS MODIFIED. THE RESULTING DOSE DISPLAYED SHOWED AREAS OF DOSE OUTSIDE THE TREATMENT FIELD, WHICH PROMPTED THE PHYSICIST TO QUESTION THE DOSE. A WORKAROUND WAS USED, THAT RESULTED IN THE PROPERLY DISPLAYED DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACQPLAN 5.0 MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM LHN PHILIPS MEDICAL SYSTEMS ACQPLAN *

    Patients

    Seq Age Sex Outcome Treatment
    1 *