FDA Adverse Event
Injury
Summary report: N
GE OEC 9800
MDR report key: 1033111
·
Received April 23, 2008
Report
- Report Number
- 1720753-2008-20839
- Event Type
- Injury
- Date Received
- April 23, 2008
- Date of Event
- April 10, 2008
- Report Date
- April 22, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND INFORMED THE CUSTOMER OF THE KNOWN SOFTWARE PROBLEM THAT WILL BE RESOLVED IN THE NEXT SOFTWARE RELEASE. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED MISSING CINE RUNS. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |