FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1071071
·
Received July 10, 2008
Report
- Report Number
- 1720753-2008-22860
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- June 13, 2008
- Report Date
- June 24, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM'S LEFT MONITOR IS DEAD. THE CUSTOMER WAS ABLE TO TRANSFER IMAGES TO THE RIGHT MONITOR. THE SYSTEM WAS REBOOTED THEN THE RIGHT SCREEN WENT OUT. 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. | GE OEC 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |