FDA Adverse Event Malfunction Summary report: N

BRAINLAB

MDR report key: 1036089 · Received April 29, 2008

Report

Report Number
MW5006491
Event Type
Malfunction
Date Received
April 29, 2008
Report Date
April 29, 2008
Manufacturer
BRAINLAB INC.
Product Code
MUJ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE PROD IN QUESTION IS "IPLAN RT IMAGE 3.0" FROM BRAINLAB. THIS IS COMPUTER SOFTWARE FOR RADIATION THERAPY THAT ALLOWS US TO SEGMENT - "CONTOUR" OR DRAW - REGIONS OF INTEREST IN ORDER TO DEFINE TREATMENT PARAMETERS. IN THE STRUCTURE SEGMENTATION PART OF THE PROD, THERE IS AN "OBJECT MANIPULATION" TOOL THAT ALLOWS VOLUMES TO BE EXPANDED BY DEFINED AMOUNTS. HOWEVER, THE EXPANSION TOOL SEEMS TO SYSTEMATICALLY EXPAND VOLUMES BY LESS THAN THE AMOUNT INPUT BY THE USER, DEPENDING ON THE PIXEL SIZE OF THE UNDERLYING IMAGE DATA -E.G. CT SCAN-. FOR EXAMPLE, A 3 MM EXPANSION IN THE SUPERIOR/INFERIOR DIRECTION PRODUCES NO EXPANSION AT ALL ON DATA SETS WITH 3 MM SLICE THICKNESS. IDEALLY, SUCH EXPANSION SHOULD ADD ONE SLICE SUPERIORLY AND ONE SLICE INFERIORLY TO THE VOLUME, AS WELL AS PROPAGATING THAT EXPANSION FOR INTERMEDIATE SLICES. OBVIOUSLY THE SOFTWARE CAN'T EXPAND VOLUMES BY LESS THAN THE RESOLUTION OF THE UNDERLYING DATA SET, BUT WHEN THE REQUESTED EXPANSION IS THE SAME AS THE UNDERLYING DATA SET, IT IS REASONABLE TO EXPECT THE EXPANSION TO OCCUR. DIAGNOSIS OR REASON FOR USE: STEROTACTIC RADIATION THERAPY TREATMENT PLANNING. DATES OF USE: 2007-2008.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BRAINLAB IPLAN RT IMAGE 3.0 MUJ BRAINLAB INC.

Patients

Seq Age Sex Outcome Treatment
1