FDA Adverse Event
Malfunction
Summary report: N
6600
MDR report key: 1921645
·
Received December 7, 2010
Report
- Report Number
- 1720753-2010-04499
- Event Type
- Malfunction
- Date Received
- December 7, 2010
- Date of Event
- November 11, 2010
- Report Date
- December 7, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER CANCELED THE SERVICE CALL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 6600 SYSTEM WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |