FDA Adverse Event
Malfunction
Summary report: N
6600
MDR report key: 2850505
·
Received November 27, 2012
Report
- Report Number
- 1720753-2012-09728
- Event Type
- Malfunction
- Date Received
- November 27, 2012
- Date of Event
- November 13, 2012
- Report Date
- November 27, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND ADJUSTED THE CAMERA AND RESEATED CIRCUIT BOARDS AND CONNECTORS. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WAS UNABLE TO PERFORM FLUOROSCOPY X-RAY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |