FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2202212
·
Received August 5, 2011
Report
- Report Number
- 1720753-2011-20737
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 28, 2011
- Report Date
- August 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP REPLACED SYSTEM SOFTWARE AND THE JOYSTICK. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE TOUCH SCREEN DID NOT FUNCTION PROPERLY AND THE JOYSTICK WAS NOT WORKING. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |