FDA Adverse Event
Malfunction
Summary report: N
OCENTRA MASTERPLAN
MDR report key: 2427080
·
Received January 5, 2012
Report
- Report Number
- 9611894-2012-00001
- Event Type
- Malfunction
- Date Received
- January 5, 2012
- Date of Event
- December 5, 2011
- Report Date
- January 5, 2012
- Manufacturer
- NUCLETRON, B.V.
- Product Code
- MUJ
- PMA / PMN Number
- K081281
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NUCLETRON SENT A CUSTOMER INFO BULLETIN 555.00205 TO OUR USERS.
Description of Event or Problem · 1
IN ONCENTRA MASTERPLAN TREATMENT PLANNING SYSTEM V4.1 ROI SIMPLIFICATION AFTER DELETING IMAGES CAUSES MISSHAPED ROIS. ONE PT HAS BEEN IDENTIFIED WHERE THE BUG HAD OCCURRED, CAUSING INCORRECT OUTLINES AND INCORRECT TREATMENT TO BE DELIVERED. IT IS ESTIMATED THAT THE VOLUME OF BRAIN TISSUE ADJACENT TO THE PLANNING TARGET VOLUME WILL HAVE RECEIVED A DOSE 10% GREATER THAN THAT WHICH WOULD HAVE BEEN RECEIVED IF THE OUTLINING INCIDENT HAD NOT OCCURRED. THE TYPE OF INJURY IS CLASSIFIED AS MINOR BY THE HOSP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCENTRA MASTERPLAN | OTP SOFTWARE | MUJ | NUCLETRON, B.V. | 170.700 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |