FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2042905
·
Received March 25, 2011
Report
- Report Number
- 1720753-2011-02831
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE SUPPLY REGULATOR, FILAMENT DRIVE, GENERATOR DRIVER, AND THE SNUBBER BOARD WERE ALL REPLACED. ALSO, THE GENERATOR AND FILAMENT CIRCUITS WERE RECALIBRATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED INTERMITTENTLY THE SYSTEM FAILED TO DISPLAY AN IMAGE. NO REPORT OF PATIENT INJURY.
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 |