FDA Adverse Event
Malfunction
Summary report: N
2600
MDR report key: 1002758
·
Received February 26, 2008
Report
- Report Number
- 1720753-2008-16394
- Event Type
- Malfunction
- Date Received
- February 26, 2008
- Date of Event
- February 18, 2008
- Report Date
- February 26, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFO AT THIS TIME. WHEN ADDITIONAL INFO IS PROVIDED, IT WILL BE REPORTED AS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMAGES ON THE 2600 SYSTEM ARE GRAINY AND THE SYSTEM PRESENTED MA ERRORS. IT WAS ALSO NOTED THAT THE SYSTEM IS NOT REGULATING AND MAKING NOISY IMAGES. THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS, INC. | 2600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |