FDA Adverse Event
Malfunction
Summary report: N
PRECISE DESKTOP 4.1
MDR report key: 532985
·
Received March 15, 2004
Report
- Report Number
- 9617016-2004-00005
- Event Type
- Malfunction
- Date Received
- March 15, 2004
- Date of Event
- January 16, 2004
- Report Date
- March 15, 2004
- Manufacturer
- ELEKTA LTD.
- Product Code
- IYE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIST
Narratives
Description of Event or Problem · 1
LINAC RUNNING ON DESKTOP 4.1 AND CONNECTED TO IMPAC SYSTEM. ALREADY DELIVERED FIELDS FROM THE LINAC WERE NOT TRANSFERRED IN A SAFE MANNER BACK TO THE IMPAC SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISE DESKTOP 4.1 | MEDICAL LINEAR ACCELERATOR CONTROL SYSTEM | IYE | ELEKTA LTD. | RT DESKTOP, R4.1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |