FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2092448
·
Received May 2, 2011
Report
- Report Number
- 1720753-2011-06813
- Event Type
- Malfunction
- Date Received
- May 2, 2011
- Date of Event
- April 15, 2011
- Report Date
- May 2, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE BOARDS IN THE WORKSTATION AND VIDEO CONNECTIONS WERE RESEATED. THE INTERCONNECT CABLE WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S MONITOR SCREEN WAS FLICKERING, THE IMAGES WERE UNSTABLE AND THAT THE UNIT HAD VIDEO PROBLEMS DURING A PROCEDURE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |