FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 1378971
·
Received May 12, 2009
Report
- Report Number
- 1720753-2009-01094
- Event Type
- Malfunction
- Date Received
- May 12, 2009
- Date of Event
- January 9, 2009
- Report Date
- February 4, 2009
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP TROUBLESHOOT THE SYSTEM THEN REVIEWED THE ERROR LOGS. THE PROBLEM INDICATES SBC BOOT PROBLEM, NEW SBC KIT ON ORDER. HE REPLACED THE SYSTEM SBC AND LOADED THE NEW SOFTWARE AND RELOADED THE CALIBRATION FILES. THE SYSTEM FUNCTIONS NORMALLY AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED INTERMITTENT LOSS OF A VIDEO ON THE MONITOR. ALSO, THE SYSTEM INTERMITTENTLY WILL BOOT WHEN COLD. IT REQUIRES A REBOOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |