FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3802094
·
Received December 30, 2013
Report
- Report Number
- 1720753-2013-13893
- Event Type
- Malfunction
- Date Received
- December 30, 2013
- Date of Event
- December 13, 2013
- Report Date
- December 30, 2013
- 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 SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE RUI ASSEMBLY WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM DISPLAYED A JOYSTICK STUCK ON THE RUI ERROR (REMOTE USER INTERFACE). THIS WOULD CAUSE A LOSS OF MOTORIZED MOVEMENTS, WHICH COULD RESULT IN THE INABILITY TO OBTAIN VIEWS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679793 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |