FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2102156
·
Received May 19, 2011
Report
- Report Number
- 1720753-2011-07460
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- May 9, 2011
- Report Date
- May 19, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE UPPER STEERING UNIVERSAL JOINT WAS CLEANED AND LUBRICATED AND THE STEERING ASSEMBLY WAS REASSEMBLED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM HAD A PROBLEM WITH THE STEERING ON THE C-ARM OUTSIDE OF A CASE. 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 |