FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1021760
·
Received March 19, 2008
Report
- Report Number
- 1720753-2008-19785
- Event Type
- Malfunction
- Date Received
- March 19, 2008
- Date of Event
- March 6, 2008
- Report Date
- March 18, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED FAILURE COULD NOT BE DUPLICATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE REMOTE USER INTERFACE (RUI) JOYSTICK WOULD NOT FUNCTION ON THE 9900 SYSTEM. IT WAS NOTED THAT THIS PROBLEM CAUSED THE SYSTEM TO LOCK UP. REBOOT REQUIRED TO COMPLETE THE CASE. THERE WAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9900 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |