FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2201381
·
Received August 3, 2011
Report
- Report Number
- 1720753-2011-20668
- Event Type
- Malfunction
- Date Received
- August 3, 2011
- Date of Event
- July 20, 2011
- Report Date
- August 3, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE FLUORO FUNCTIONS BOARD AND THE GENERATOR INTERFACE BOARD WERE RESEATED. THE FLASH MEMORY AND CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN ERROR MESSAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |