FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2193177
·
Received July 21, 2011
Report
- Report Number
- 1720753-2011-20276
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- July 7, 2011
- Report Date
- July 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. TWO CIRCUIT CARDS WERE REPLACED AND THE CONNECTIONS ON THE REMOTE USER INTERFACE PLUG WERE REPAIRED. 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 THERE WAS A COMMUNICATION ERROR BETWEEN THE REMOTE USER INTERFACE AND THE GENERATOR. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |