FDA Adverse Event
Malfunction
Summary report: N
XIO RTP SYSTEM
MDR report key: 707650
·
Received November 22, 2005
Report
- Report Number
- 1937649-2005-00001
- Event Type
- Malfunction
- Date Received
- November 22, 2005
- Date of Event
- August 31, 2005
- Report Date
- November 22, 2005
- Manufacturer
- COMPUTERIZED MEDICAL SYSTEMS, INC.
- Product Code
- IYE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IN CASES WHERE A DOSIMETRIST IS USING A SIEMENS LINEAR ACCELERATOR WHERE THE MLC SERVES AS A COLLIMATOR JAW REPLACEMENT, THE MLC'S DEFINE A STRAIGHT EDGE IN A PORT, AND THE COLLIMATOR IS SET TO COINCIDE WITH THIS STRAIGHT EDGE, XIO UNDERESTIMATES THE PENUMBRAL DOSE UNDER THIS EDGE. NO PATIENTS HAVE BEEN MISTREATED AS A RESULT OF THIS PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIO RTP SYSTEM | RADIATION TREATMENT PLANNING SYSTEM | IYE | COMPUTERIZED MEDICAL SYSTEMS, INC. | ALL | 2.1.0-4.3.0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |