FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2101576
·
Received May 11, 2011
Report
- Report Number
- 1720753-2011-07175
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 22, 2011
- Report Date
- May 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE TRANSITION BOARD, THE CONTROLLER BOARD, AND THE UNIVERSAL NODE CONTROLLER BOARD WERE REPLACED. THE NODES WERE RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN X-RAY ON AND AN X-RAY DISABLED ERROR MESSAGE. 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 (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |