FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9600
MDR report key: 1040751
·
Received May 9, 2008
Report
- Report Number
- 1720753-2008-21406
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- April 29, 2008
- Report Date
- May 8, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP HAS EVALUATED THIS SYSTEM AND FOUND THE IMAGE INTENSIFIER TO BE FAULTY. THOUGH, THE CUSTOMER CHOSE TO HAVE THEIR BIOMED DEPT. ENGINEERS REPAIR THE SYSTEM.
Description of Event or Problem · 1
CUSTOMER REPORTED AUTO FOCUS ON IMAGING WAS NOT WORKING PROPERLY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |