FDA Adverse Event
Injury
Summary report: N
ADAC PINACLE 3
MDR report key: 522097
·
Received September 29, 2003
Report
- Report Number
- 522097
- Event Type
- Injury
- Date Received
- September 29, 2003
- Date of Event
- January 23, 2003
- Report Date
- September 25, 2003
- Manufacturer
- ADAC LABORATORIES
- Product Code
- MUJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OR, US
- Reporter Occupation
- RISK MANAGER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAC PINACLE 3 | TREATMENT PLANNING COMPUTER | MUJ | ADAC LABORATORIES | * | * | |
| 2 | DICOM RT | INFORMATION TRANSFER COMPUTER | LMD | PHILLIPS/ADAC | * | * | |
| 3 | IMPAC MULTI ACCESS | ELECTRONIC PATIENT CHART | LNX | IMPAC | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Required Intervention | DICOM & IMPAC RT. |