FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2031037
·
Received March 4, 2011
Report
- Report Number
- 1720753-2011-01960
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- January 27, 2011
- Report Date
- March 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SNUBBER BOARD, INTERCONNECT CABLE, X-RAY TUBE AND THE HIGH VOLTAGE CABLE WERE REPLACED. FILAMENT CALIBRATIONS WERE PERFORMED AND THE COLLIMATOR WAS CENTERED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A LOW MILLIAMP ERROR MESSAGE AND THAT SIGNS OF ARCING WERE VISIBLE ON THE X-RAY TUBE AND THE HIGH VOLTAGE CABLE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |