FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2092191
·
Received April 27, 2011
Report
- Report Number
- 1720753-2011-06619
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- March 16, 2011
- Report Date
- April 27, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN INVESTIGATION BY TELEPHONE. THE POWER SUPPLY PROBLEMS WERE RESOLVED BY THE CUSTOMER WITH TECHNICAL SUPPORT FROM THE MFR. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 2800 SYSTEM WOULD NOT POWER ON AND THERE WAS GENERATOR ERROR MESSAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |