FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 1993289
·
Received February 7, 2011
Report
- Report Number
- 9680959-2011-00292
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- December 4, 2009
- Report Date
- February 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PROVIDED PHONE SUPPORT FOR THE CUSTOMER. REPAIRS TO THE SYSTEM WERE NOT DISCLOSED. HOWEVER, THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THE SYSTEM DISPLAYED A COMMUNICATION FAILED ERROR MESSAGE. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |