FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 1992950
·
Received February 5, 2011
Report
- Report Number
- 9680959-2011-00274
- Event Type
- Malfunction
- Date Received
- February 5, 2011
- Date of Event
- December 8, 2009
- Report Date
- February 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CENTRAL PROCESSING COMPUTER REQUIRED REPLACEMENT. HOWEVER, THE CUSTOMER CHOSE NOT TO REPAIR THE SYSTEM.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM FAILED TO BOOT UP. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7700 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |