FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2042338
·
Received February 15, 2011
Report
- Report Number
- 1720753-2011-02283
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- December 17, 2010
- Report Date
- March 15, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE PS3 POWER SUPPLY WAS REPLACED DURING THE SVC CALL. THE SYS 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 VERTICAL LIFT COLUMN ON THE 9800 SYS WOULD NOT WORK. 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 |