FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2152515
·
Received June 27, 2011
Report
- Report Number
- 1720753-2011-08565
- Event Type
- Malfunction
- Date Received
- June 27, 2011
- Date of Event
- June 7, 2011
- Report Date
- June 27, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION AND REPLACED THE FOLLOWING: THE X-RAY TUBE, THE HIGH VOLTAGE TANK, THE FILAMENT DRIVER PRINTED CIRCUIT BOARD, THE SNUBBER AND THE SNUBBER INSULATORS. THE GENERATOR WAS CALIBRATED AND THE BEAM WAS ALIGNED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A KV ERROR MESSAGE DURING A CASE. NO PT 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 |