FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2884824
·
Received December 3, 2012
Report
- Report Number
- 1720753-2012-09928
- Event Type
- Malfunction
- Date Received
- December 3, 2012
- Date of Event
- November 9, 2012
- Report Date
- November 30, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE RUI (JOYSTICK) AND MCU BOARD WERE REPLACED. THE SYS WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE RUI/JOYSTICK (REMOTE USER INTERFACE) WAS NOT WORKING. WHEN THE MOTORIZED MOVEMENTS ARE COMPLETELY DOWN, THE CRANIAL AND CAUDAL MOVEMENTS ARE NOT AVAILABLE, WHICH WOULD RENDER THE SYSTEM UNUSABLE FOR ITS SPECIFIC PURPOSE. THERE IS NO REPORT OF PT INJURY.
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 |