FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2041473
·
Received March 24, 2011
Report
- Report Number
- 1720753-2011-02730
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE POWER SUPPLY AND BACKPLANE, AND RESEATED ALL CONNECTORS AND POWER SUPPLIES. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS A GENERATOR ERROR MESSAGE ON THE 6800 SYSTEM. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |