FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1173013
·
Received September 19, 2008
Report
- Report Number
- 1720753-2008-26112
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- September 5, 2008
- Report Date
- September 19, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP REPLACED THE SYSTEM INTERFACE AND IMAGE PROCESSOR. SYSTEM IS NOW ABLE TO PERFORM X-RAY FUNCTIONS AS INTENDED, AND DOES NOT SHUT ITSELF OFF.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM GIVES WORKSTATION FATAL ERROR AND GIB DISCONNECT ERRORS. THE SYSTEM NEEDS A SYSTEM INTERFACE AND IMAGE PROCESSOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |