FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2191633
·
Received July 20, 2011
Report
- Report Number
- 1720753-2011-20236
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- July 10, 2011
- Report Date
- July 20, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE VOLTAGE WAS ADJUSTED AND THE NODES WERE FLASHED AND RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE MONITOR ON THE SYSTEM WAS BLACK. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |