FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2030516
·
Received March 9, 2011
Report
- Report Number
- 1720753-2011-02065
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- February 15, 2011
- Report Date
- March 9, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN OVER THE PHONE INVESTIGATION. THE KEY SWITCH POSITION WAS SWITCHED TO ON DURING THE SERVICE CALL. THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE VERTICAL LIFT COLUMN ON THE 9800 SYSTEM WOULD NOT WORK DURING A CASE. THE PROCEDURE WAS COMPLETED. 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 |