FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 3801996
·
Received February 4, 2014
Report
- Report Number
- 9680959-2014-00187
- Event Type
- Malfunction
- Date Received
- February 4, 2014
- Date of Event
- September 27, 2013
- Report Date
- February 4, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE EMERGENCY SWITCH WAS EVALUATED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE FSE REPORTED THAT THE SYSTEM FAILED TO BOOT TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PT SERIOUS INJURY OF DEATH WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73543 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |