FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2042973
·
Received March 25, 2011
Report
- Report Number
- 1720753-2011-02848
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CONNECTORS ON THE FILAMENT REGULATOR BOARD WERE RESEATED AND CALIBRATION ON THE GENERATOR WAS PERFORMED. THE II GRID, AC POWER CORD, AND UNINTERRUPTED POWER SUPPLY SWITCH WERE REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9900 SYSTEM PRODUCED A FILAMENT REGULATOR FAULT MESSAGE DURING A PROCEDURE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |