FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2193206
·
Received July 21, 2011
Report
- Report Number
- 1720753-2011-20254
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- July 12, 2011
- Report Date
- July 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE SVC REP REPLACED THE SYSTEM INTERFACE AND THE CONTROLLER. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD DISPLAY COMMUNICATION FAILURE AND MA ERROR MESSAGES. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |