FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2241102
·
Received August 17, 2011
Report
- Report Number
- 1720753-2011-21132
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 11, 2011
- Report Date
- August 17, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE VIDEO CONTROLLER WAS CHECKED AND LOOSE. VOLTAGES AT PS1 AND PS2 WERE CHECKED AND WITHIN TOLERANCE, HOWEVER, THE CONNECTION AT PS2 WAS RESEATED. THE CONNECTIONS ON THE MONOBLOCK AND THE ENCODER PRINTED CIRCUIT BOARD WERE CHECKED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO CAPTURE X-RAYS, THE SYSTEM DISPLAYED AN X-RAY DISABLED ERROR MESSAGE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |