FDA Adverse Event
Malfunction
Summary report: N
2500
MDR report key: 1000876
·
Received February 21, 2008
Report
- Report Number
- 1720753-2008-16264
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- February 12, 2008
- Report Date
- February 20, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER CANCELLED THE SERVICE CALL. CUSTOMER STATED THEY WILL REPLACE THE BATTERY PACK. NO ADDITIONAL INFO.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LARGE FOCAL SPOT IMAGES ON THE 2500 SYSTEM ARE NON DIAGNOSTIC (LIGHT), BUT THE SMALL SPOT ARE OK. THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2500 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 2500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |