FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2101598
·
Received May 11, 2011
Report
- Report Number
- 1720753-2011-07184
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 26, 2011
- Report Date
- May 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE IRIS STOPS WERE CALIBRATED, THE ENTRANCE "DOES" WAS ADJUSTED, AND THE CAMERA WAS ADJUSTED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED POOR IMAGE QUALITY. 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 |