FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3811049
·
Received March 24, 2014
Report
- Report Number
- 1720753-2014-02640
- Event Type
- Malfunction
- Date Received
- March 24, 2014
- Date of Event
- March 4, 2014
- Report Date
- March 24, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE.
Description of Event or Problem · 1
THE FE REPORTED THE SYS DISPLAYED AN AD CHANNEL FAILURE ERROR MESSAGE. THIS MESSAGE WILL RESULT IN A NO BOOT SITUATION. THERE ARE NO REPORTS OF PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173394 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |