FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2030990
·
Received March 4, 2011
Report
- Report Number
- 1720753-2011-01933
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- February 8, 2011
- Report Date
- March 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE FLUORO FUNCTIONS BOARD AND THE POWER SUPPLY. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AFTER TAKING AN X-RAY THE LEFT MONITOR WAS BLACK ON THE 9800 SYSTEM. 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 |