FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 2043549
·
Received March 28, 2011
Report
- Report Number
- 9680959-2011-00885
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- May 6, 2010
- Report Date
- March 28, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE COLLIMATOR WAS CALIBRATED. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN ERROR CODE=20 ERROR MESSAGE WAS DISPLAYED ON THE 7700 SYSTEM AND THAT THE STORED IMAGES DISAPPEARED WHEN THE SYSTEM WAS TURNED OFF. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7700 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |