FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2101788
·
Received May 10, 2011
Report
- Report Number
- 1720753-2011-07136
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 22, 2011
- Report Date
- May 10, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP REPLACED THE X-RAY TUBE HEAD, THE TEMP SENSOR, BOTH WORKSTATION MONITORS, AND THE SINGLE BOARD COMPUTER PRINTED CIRCUIT BOARD, LOADED THE SOFTWARE, PERFORMED CAMERA AND COLLIMATOR CALIBRATION, AND ADJUSTED THE MILLIAMP NULL LIMITS AND VOLTAGES ON THE FLUORO FUNCTIONS BOARD PRINTED CIRCUIT BOARD. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN HIGH MILLIAMP AND ANODE TOO HOT ERROR MESSAGES. NO PT 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 |