FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2043380
·
Received March 28, 2011
Report
- Report Number
- 1720753-2011-02903
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 28, 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 ON SITE INVESTIGATION. THE REMOTE USER INTERFACE ASSEMBLY (JOYSTICK) AND THE CONTROL PANEL DISPLAY ON THE MAINFRAME WERE REPLACED. THE SYS WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE JOYSTICK WAS NOT WORKING AND THE CONTROL PANEL DISPLAY ON THE MAINFRAME WAS BROKEN. 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 |