FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2090018
·
Received April 11, 2011
Report
- Report Number
- 1720753-2011-03525
- Event Type
- Malfunction
- Date Received
- April 11, 2011
- Date of Event
- March 24, 2011
- Report Date
- April 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE INTERCONNECT CABLE, GENERATOR INTERFACE BOARD, AND THE UNIVERSAL MICRO CONTROLLER, AND ADJUSTED THE ISOLATION TRANSFORMER SETTINGS. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM DISPLAYED A COMMUNICATION ERROR MESSAGE. 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 |