FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2102109
·
Received April 20, 2011
Report
- Report Number
- 1720753-2011-06375
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 20, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE MONITOR WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE LEFT MONITOR OF THE 9800 SYSTEM WOULD BURN OUT FROM THE SCREEN SAVER AND SHOW UP ON ALL OF THE IMAGES. 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 |