FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1992927
·
Received February 5, 2011
Report
- Report Number
- 1720753-2011-00967
- Event Type
- Malfunction
- Date Received
- February 5, 2011
- Date of Event
- December 14, 2010
- Report Date
- February 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP CONTACTED THE CUSTOMER OVER THE PHONE AND DIRECTED THE CUSTOMER IN REPAIR OF THE SYSTEM. NO EVALUATION RESULTS WERE REPORTED, BUT THE SYSTEM WAS REPORTED AS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE IMAGE DISAPPEARED, AND LATER CAME BACK. 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 |