FDA Adverse Event
Malfunction
Summary report: N
HI-ART SYSTEM
MDR report key: 1733911
·
Received June 8, 2010
Report
- Report Number
- 3003873069-2010-00003
- Event Type
- Malfunction
- Date Received
- June 8, 2010
- Report Date
- May 27, 2010
- Manufacturer
- TOMOTHERAPY INCORPORATED
- Product Code
- MUJ
- PMA / PMN Number
- K082005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
METHOD: SOFTWARE CODE REVIEW PERFORMED. CONCLUSIONS: NOT TYPICAL WORKFLOW.
Description of Event or Problem · 1
THE PLANNING STATION'S PRINTED PLAN REPORT MAY INDICATE DOSE STATISTICS WHICH ARE NOT CORRECT. TREATMENTS INTERNAL TO TOMOTHERAPY'S HI-ART TREATMENT SYSTEM ARE NOT APPROVED BASED ON PRINTED PLAN REPORT DOSE STATISTICS. HOWEVER, IF ERRONEOUS DOSE STATISTICS WERE PROVIDED TO THIRD PARTIES TO GUIDE THERAPY IN RE-TREATMENT SITUATIONS, IMPROPER THERAPY COULD RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HI-ART SYSTEM | IYE AND MUJ | MUJ | TOMOTHERAPY INCORPORATED | H-0000-0003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |