FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2090681
·
Received April 26, 2011
Report
- Report Number
- 1720753-2011-06593
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 26, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REP CONDUCTED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE GENERATOR AND THE GENERATOR BATTERIES WERE REPLACED. THE TUBE LIGHT WAS CALIBRATED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9800 SYSTEM DISPLAYED A FILAMENT REGULATOR AND A PRECHARGE FAILURE 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 |