OtherMUJ
ECLIPSE
Received Jul 13, 2006 · Event occurred Jun 15, 2006
Report 3003793371-2006-00006 · MDR key 735689
Device
Generic name
Treatment Planning System
Manufacturer
Varian Medical Systems, Finland 0yModel number
*Catalog number
48
Lot number
*
Product problems
- Use of Device Problem
Patient
*
- Underdose
Narrative
Description of Event or Problem
THE CUSTOMER REPORT INDICATES THAT DURING RADIATION THERAPY TREATMENT, THE PATIENT'S TREATMENT PLAN DID NOT INCLUDE THE BOLUS, RESULTING IN 100CGY UNDER DOSE. THE PHYSICIAN REVIEWED THE PLAN AND DECIDED TO ADJUST THE DOSAGE OVER THE REMAINING 12 FRACTIONS BY CREATING A NEW PLAN, LINKING THE BOLUS WITH THE NEW DOSE/FRACTION TO COMPENSATE FOR THE PREVIOUS TREATMENTS.
Additional Manufacturer Narrative
NO MALFUNCTION OF THE DEVICE OCCURRED IN THIS INCIDENT. THIS IS THE CORRECT FUNCTIONALLY OF THE SOFTWARE. USER ERROR RELATED.