FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2043384
·
Received March 28, 2011
Report
- Report Number
- 1720753-2011-02897
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 28, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SVC REP PERFORMED AN ON-SITE INVESTIGATION. THE SVC REP RESEATED THE CONNECTIONS BETWEEN THE HV TANK AND BOARD, AND PERFORMED FILAMENT CALIBRATION. THE SYS WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9800 SYS DISPLAYED A MA SENSOR FAIL ERROR MESSAGE. 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 |