FDA Adverse Event
Summary report: N
GEMINI GXL 16 POWER
MDR report key: 1647257
·
Received March 16, 2010
Report
- Report Number
- 1647257
- Date Received
- March 16, 2010
- Date of Event
- February 26, 2010
- Report Date
- March 12, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
- Product Code
- KPS
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PATIENT UNDERWENT A SCHEDULED OUTPATIENT BRAIN CT SCAN. THE TECHNICIAN PROGRAMMED THE MACHINE AT 800 MA INSTEAD OF 80 MA. THE DEPARTMENT OF HEALTH SERVICES RADIATION DEPARTMENT DID NOT REQUIRE A REPORT TO BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEMINI GXL 16 POWER | PET CT SCANNER | KPS | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. | GEMINI GXL 16 POWER | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR |