FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 1441021
·
Received August 18, 2009
Report
- Report Number
- 1720753-2009-03203
- Event Type
- Malfunction
- Date Received
- August 18, 2009
- Date of Event
- March 27, 2009
- Report Date
- April 22, 2009
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B) (4). THE SYSTEM IP PCB ASSEMBLY WAS RESEATED. THE SYSTEM OPERATES AS INTENDED. (B) (4)06/18/2009.
Description of Event or Problem · 1
THE CUSTOMER REPORTS THAT THE IMAGE WAS UNREADABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |