FDA Adverse Event
Malfunction
Summary report: N
GE OEC 2800
MDR report key: 1021016
·
Received March 28, 2008
Report
- Report Number
- 1720753-2008-18068
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- July 1, 2004
- Report Date
- March 26, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND RESET THE CMOS MEMORY. SYSTEM OPERATES AS INTENDED. THE TOTAL NUMBER OF EVENT BEING SUMMARIZED. PLEASE NOT THE MDRS ASSOCIATED WITH THIS REPORT ARE FILED LATE IN RESPONSE TO THE REMEDIATION EFFORTS OF GE HEALTHCARE. THIS REPORT IS FILED UNDER THE FDA'S RETROSPECTIVE SUMMARY REPORT.
Description of Event or Problem · 1
CUSTOMER REPORTED THE SYSTEM WAS DISPLAYING A COMMUNICATION ERROR. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 2800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |