FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 1992873
·
Received February 5, 2011
Report
- Report Number
- 1720753-2011-00960
- Event Type
- Malfunction
- Date Received
- February 5, 2011
- Date of Event
- January 24, 2011
- Report Date
- February 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND ADJUSTED THE CAMERA IRIS, BUT THE IMAGE INTENSIFIER NEEDS TO BE REPLACED. CUSTOMER HAS NOT YET DECIDED TO REPAIR THE SYSTEM.
Description of Event or Problem · 1
THE CUSTOMER REPORTED POOR IMAGE QUALITY. THE IMAGES ARE TOO DARK. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |