FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 3843389
·
Received March 14, 2014
Report
- Report Number
- 1720753-2014-02337
- Event Type
- Malfunction
- Date Received
- March 14, 2014
- Date of Event
- February 21, 2014
- Report Date
- March 14, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CONTACTS ON THE CONTROL PANEL PCB WERE CLEANED. 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 GENERATOR ERROR MESSAGE, WHICH WILL LIKELY RESULT IN A SYSTEM LOCK UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152420 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |