FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2153428
·
Received June 21, 2011
Report
- Report Number
- 1720753-2011-08383
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE GENERATOR INTERFACE BOARD AND THE SYSTEM'S HIGH VOLTAGE TANK WERE REPLACED. FILAMENT CALIBRATION AND HIGH VOLTAGE ARC TESTS WERE PERFORMED AND THE SYSTEM'S CONFIGURATION FILES WERE UPDATED WITH NEW DATA. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A KILOVOLT ERROR MESSAGE ON THE CONTROL PANEL WHEN THE FLUOROSCOPY BUTTON WAS DEPRESSED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |