FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 1353548
·
Received February 12, 2009
Report
- Report Number
- 9617766-2009-00053
- Event Type
- Malfunction
- Date Received
- February 12, 2009
- Date of Event
- January 13, 2009
- Report Date
- February 10, 2009
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP FOUND THE SBC PCB WAS OUT OF ORDER. THIS SBC PCB WAS THE OLD VERSION SO HE ORDERED THE NEW VERSION SBC PCB AND UPGRADED THE SYSTEM. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE SYSTEM INTERMITTENTLY DID NOT X-RAY OR DID NOT DISPLAY THE FLUORO IMAGES. THE CUSTOMER REBOOT THE SYSTEM SEVERAL TIMES BEFORE IT BEGAN TO PROPERLY FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |