FDA Adverse Event
Summary report: N
PHILIPS PINNACLE 3
MDR report key: 2240680
·
Received September 2, 2011
Report
- Report Number
- 2240680
- Date Received
- September 2, 2011
- Date of Event
- April 14, 2011
- Report Date
- September 2, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS N. A.
- Product Code
- MUJ
- Report Source
- User Facility report
- Reporter Location
- ME, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE PINNACLE TREATMENT PLANNING SYSTEM HAS PROMPTS THAT ARE NOT USED AT OUR FACILITY. STAFF NEED TO CLICK THROUGH THE PROMPTS AS THEY CANNOT BE HIDDEN. STAFF "PASSED OVER" THE ONE PROMPT FOR LOCALIZATION WHICH RESULTED IN TREATMENT FIELDS BEING 9 CM OFF DESIRED TREATMENT AREA. ADDITIONAL PROMPTS HAVE BEEN ADDED TO THE SYSTEM FOR USING THE LOCALIZATION FEATURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHILIPS PINNACLE 3 | RADIOTHERAPY TREATMENT PLANNING SOFTWARE | MUJ | PHILIPS MEDICAL SYSTEMS N. A. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |