FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2031271
·
Received March 16, 2011
Report
- Report Number
- 1720753-2011-02379
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 21, 2011
- Report Date
- March 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE IMAGE PROCESSOR AND ALL CONNECTIONS ON THE POWER SUPPLY WERE RESEATED AS WELL AS THE PCB'S IN THE WORK STATION. THE SYSTEM WAS TESTED AND IS NOW OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM HAD POOR IMAGE QUALITY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |