FDA Adverse Event
Malfunction
Summary report: N
6600
MDR report key: 2030212
·
Received March 7, 2011
Report
- Report Number
- 1720753-2011-01969
- Event Type
- Malfunction
- Date Received
- March 7, 2011
- Date of Event
- February 24, 2011
- Report Date
- March 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REP CONDUCTED AN ONSITE INVESTIGATION. THE REP RESEATED THE PRINTED CIRCUIT BOARDS AND CONNECTORS. THE SYSTEM WAS TESTED AND IS NOW OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 6600 SYSTEM DISPLAYED A OVERHEATING ERROR MESSAGE AND 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 |