FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2092239
·
Received April 27, 2011
Report
- Report Number
- 1720753-2011-06661
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 27, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REPRESENTATIVE CONDUCTED AN ON SITE INVESTIGATION. THE SNUBBER PCB, THE HIGH VOLTAGE TRANSFORMER TANK, THE GENERATOR DRIVER PCB, THE BACKPLANE PCB, THE HIGH VOLTAGE CABLE, THE HIGH VOLTAGE IGBT WITH INSULATORS, AND THE X-RAY TUBE WERE REPLACED. THE FILAMENTS WERE CALIBRATED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM DISPLAYED AN OVERLOAD FAULT ERROR. 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 |